Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
Study NCT ID:
NCT01500759
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2011-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002639', 'term': 'Cheyne-Stokes Respiration'}, {'id': 'D020182', 'term': 'Sleep Apnea, Central'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalResearch&Strategy@ResMed.com', 'phone': '089990100', 'title': 'Medical Affairs CRS', 'organization': 'ResMed Germany Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Non-serious adverse events were not collected in this observational study. Usual side-effects of therapy in clinical routine are well described. Serious adverse events (SAE) were recorded, but in this observational study only those in connection to the device: Unexpected serious device defects (USADE). No device effects were recorded during the course of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 3686, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 3190, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of SDB in Chronic HF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6876', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '3190', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility', 'description': 'SDB= Sleep disordered breathing; HF= Heart failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution', 'description': 'Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole', 'unitOfMeasure': '% ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '12', 'groupId': 'OG000'}, {'value': '69', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-time single assessment at baseline', 'description': 'Age years', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-time single assessment at baseline', 'unitOfMeasure': 'kg/m˄2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Male Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '2754', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time single assessment at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NYHA Class ≥III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '2566', 'groupId': 'OG000'}, {'value': '2341', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records', 'description': 'New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ischemic Etiology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '1961', 'groupId': 'OG000'}, {'value': '1742', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.', 'description': 'Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '863', 'groupId': 'OG000'}, {'value': '1001', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nocturnal Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '672', 'groupId': 'OG000'}, {'value': '800', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nocturia ≥3 Times/Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '580', 'groupId': 'OG000'}, {'value': '660', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline nocturia was assessed 1 time (anamnesis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apnoea-Hypopnea-Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '4', 'groupId': 'OG000'}, {'value': '31', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Desaturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '10', 'groupId': 'OG000'}, {'value': '24', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean SpO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'spread': '2', 'groupId': 'OG000'}, {'value': '92', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Saturation of oxygen', 'unitOfMeasure': '%oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Min SpO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '6', 'groupId': 'OG000'}, {'value': '80', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Lowest Saturation with oxygen', 'unitOfMeasure': '% oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication ACE Inhibitors and/ARBs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '3269', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'description': 'ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beta-blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '3284', 'groupId': 'OG000'}, {'value': '2824', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diuretics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2617', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Digitalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '717', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aldosterone Antagonists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'OG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'classes': [{'categories': [{'measurements': [{'value': '1808', 'groupId': 'OG000'}, {'value': '1454', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Male Gender as Predictor for SDB in Chronic HF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Chronic HF Without SDB Male', 'description': 'patients with chronic heart failure and no sleep disordered breathing who are male'}, {'id': 'OG001', 'title': 'Patients With Chronic Heart Failure and SDB Male', 'description': 'patients with chronic heart failure and sleep disorderd breathing who are male'}], 'classes': [{'categories': [{'measurements': [{'value': '2754', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Chronic HF Without SDB and AF', 'description': 'patients with chronic heart failure and no sleep disordered breathing who have atrial fibrillation (AF)'}, {'id': 'OG001', 'title': 'Patients With Chronic Heart Failure and SDB and AF', 'description': 'patients with chronic heart failure and sleep disorderd breathing who have atrial fibrillation (AF)'}], 'classes': [{'categories': [{'measurements': [{'value': '863', 'groupId': 'OG000'}, {'value': '1001', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ischemic Etiology as Predictor for SDB in Chronic HF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Chronic HF Without SDB and Ischemic Etiology', 'description': 'patients with chronic heart failure and no sleep disordered breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF'}, {'id': 'OG001', 'title': 'Patients With Chronic Heart Failure and SDB and Ischemic Etiol', 'description': 'patients with chronic heart failure and sleep disorderd breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF'}], 'classes': [{'categories': [{'measurements': [{'value': '1961', 'groupId': 'OG000'}, {'value': '1742', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.92', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NYHA Class >= III as Predictor for SDB in Chronic HF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'OG000'}, {'value': '3190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Chronic HF Without SDB and NYHA>III', 'description': 'patients with chronic heart failure and no sleep disordered breathing who are classified as NYHA \\>=III'}, {'id': 'OG001', 'title': 'Patients With Chronic Heart Failure and SDB and NYHA >III', 'description': 'patients with chronic heart failure and sleep disorderd breathing who are classified as NYHA \\>=III'}], 'classes': [{'categories': [{'measurements': [{'value': '2566', 'groupId': 'OG000'}, {'value': '2341', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'FG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3686'}, {'groupId': 'FG001', 'numSubjects': '3190'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3686'}, {'groupId': 'FG001', 'numSubjects': '3190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3686', 'groupId': 'BG000'}, {'value': '3190', 'groupId': 'BG001'}, {'value': '6876', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic HF Without SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'BG001', 'title': 'Chronic HF With SDB', 'description': 'Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '12', 'groupId': 'BG000'}, {'value': '69', 'spread': '11', 'groupId': 'BG001'}, {'value': '67', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '932', 'groupId': 'BG000'}, {'value': '516', 'groupId': 'BG001'}, {'value': '1448', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2754', 'groupId': 'BG000'}, {'value': '2674', 'groupId': 'BG001'}, {'value': '5428', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6876}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2011-12-23', 'resultsFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-25', 'studyFirstPostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of SDB in Chronic HF Patients', 'timeFrame': '1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility', 'description': 'SDB= Sleep disordered breathing; HF= Heart failure'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': '1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution', 'description': 'Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole'}, {'measure': 'Age', 'timeFrame': '1-time single assessment at baseline', 'description': 'Age years'}, {'measure': 'Body Mass Index', 'timeFrame': '1-time single assessment at baseline'}, {'measure': 'Male Gender', 'timeFrame': '1-time single assessment at baseline'}, {'measure': 'NYHA Class ≥III', 'timeFrame': 'At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records', 'description': 'New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.'}, {'measure': 'Ischemic Etiology', 'timeFrame': '1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.', 'description': 'Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.'}, {'measure': 'Atrial Fibrillation', 'timeFrame': '1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records'}, {'measure': 'Nocturnal Dyspnea', 'timeFrame': '1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records'}, {'measure': 'Nocturia ≥3 Times/Night', 'timeFrame': '1-time: At baseline nocturia was assessed 1 time (anamnesis)'}, {'measure': 'Apnoea-Hypopnea-Index', 'timeFrame': '1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep'}, {'measure': 'Oxygen Desaturation Index', 'timeFrame': '1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.'}, {'measure': 'Mean SpO2', 'timeFrame': '1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Saturation of oxygen'}, {'measure': 'Min SpO2', 'timeFrame': '1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility', 'description': 'Lowest Saturation with oxygen'}, {'measure': 'Medication ACE Inhibitors and/ARBs', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)', 'description': 'ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker'}, {'measure': 'Beta-blocker', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)'}, {'measure': 'Diuretics', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)'}, {'measure': 'Digitalis', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)'}, {'measure': 'Aldosterone Antagonists', 'timeFrame': '1-time: At baseline medication was assessed 1 time (anamnesis)'}, {'measure': 'Male Gender as Predictor for SDB in Chronic HF', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure'}, {'measure': 'Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure'}, {'measure': 'Ischemic Etiology as Predictor for SDB in Chronic HF', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure'}, {'measure': 'NYHA Class >= III as Predictor for SDB in Chronic HF', 'timeFrame': '1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)', 'description': 'From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic heart failure', 'heart failure', 'hf', 'sleep-disordered breathing', 'sdb', 'nyha', 'lvef', 'cheyne stokes', 'central sleep apnoea', 'sleep apnoea'], 'conditions': ['Congestive Heart Failure', 'Left Ventricular Systolic Dysfunction']}, 'referencesModule': {'references': [{'pmid': '24716484', 'type': 'RESULT', 'citation': 'Woehrle H, Oldenburg O, Arzt M, Graml A, Erdmann E, Teschler H, Wegscheider K; SCHLA-HF Investigators. Determining the prevalence and predictors of sleep disordered breathing in patients with chronic heart failure: rationale and design of the SCHLA-HF registry. BMC Cardiovasc Disord. 2014 Apr 9;14:46. doi: 10.1186/1471-2261-14-46.'}, {'pmid': '26682790', 'type': 'RESULT', 'citation': 'Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A, Erdmann E, Teschler H, Wegscheider K; SchlaHF Investigators. Prevalence and Predictors of Sleep-Disordered Breathing in Patients With Stable Chronic Heart Failure: The SchlaHF Registry. JACC Heart Fail. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9.'}, {'pmid': '29187390', 'type': 'RESULT', 'citation': 'Arzt M, Oldenburg O, Graml A, Erdmann E, Teschler H, Wegscheider K, Suling A, Woehrle H; SchlaHF Investigators. Phenotyping of Sleep-Disordered Breathing in Patients With Chronic Heart Failure With Reduced Ejection Fraction-the SchlaHF Registry. J Am Heart Assoc. 2017 Nov 29;6(12):e005899. doi: 10.1161/JAHA.116.005899.'}]}, 'descriptionModule': {'briefSummary': 'Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.\n\nFor this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.', 'detailedDescription': 'Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.\n\nSleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.\n\nObjective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.\n\nFor this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.\n\nCardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with Chronic Heart Failure with LVEF ≤ 45% and NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 24 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be over 18\n* Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines\n* Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks\n* NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months\n* Patient is able to fully understand study information and signed informed consent\n\nExclusion Criteria:\n\n* Life expectancy \\< 1 year for diseases unrelated to chronic HF\n* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months\n* CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months\n* Transient ischemic attack (TIA) or Stroke within 3 months\n* Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery\n* Acute myocarditis/pericarditis within 6 months\n* Current CPAP or bilevel therapy'}, 'identificationModule': {'nctId': 'NCT01500759', 'acronym': 'SchlaHF', 'briefTitle': 'Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure', 'orgStudyIdInfo': {'id': '001'}}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Rivercity Private Hospital', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Baker IDI Heart and Diabetes Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3065', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'St Vincents and Mercy Private Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria 3002', 'country': 'Australia', 'facility': 'Melbourne Sleep Disorders Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Hollywood Private Hospital (CVS)', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '55218', 'city': 'Ingelheim', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Cardiopraxis Ingelheim', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}, {'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Praxis Dr. Frieske', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '55232', 'city': 'Alzey', 'country': 'Germany', 'facility': 'DRK Krankenhaus', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, {'zip': '59821', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Weiß/ Dr. Heesing', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '99437', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinikum Bad Berka', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herzzentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Klinik Lazariterhof', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Praxis Dr. Bauer', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'HDZ NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '88410', 'city': 'Bad Wurzach', 'country': 'Germany', 'facility': 'Kardiologische Praxis Dr. Stroh', 'geoPoint': {'lat': 47.90799, 'lon': 9.89686}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Oberlausitz-Kliniken gGmbH', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '51465', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Kardiopraxis Rheinberg', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Mitte CCM', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10178', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Gemeinschaft Frille', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12157', 'city': 'Berlin', 'country': 'Germany', 'facility': 'POLIKUM Friedenau', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12355', 'city': 'Berlin', 'country': 'Germany', 'facility': 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