Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-04-24 @ 12:37 PM
Study NCT ID:
NCT03026634
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma, serum and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation'}], 'secondaryOutcomes': [{'measure': 'Apnea Index', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Apnea Index (AI /h) before and after heart transplantation'}, {'measure': 'Hypopnea Index', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Hypopnea Index (HI /h) before and after heart transplantation'}, {'measure': 'Oxygen Desaturation Index', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Oxygen Desaturation (ODI /h) before and after heart transplantation'}, {'measure': 'Time SaO2 < 90 (%)', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Time SaO2 \\< 90 (%) before and after heart transplantation'}, {'measure': 'Respiration cycle length', 'timeFrame': '30 days after heart transplantation', 'description': 'Change in Respiration cycle lengths before and after heart transplantation'}, {'measure': 'Health Questionnaires', 'timeFrame': '30 days after heart transplantation', 'description': "Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)"}, {'measure': 'Health Questionnaires', 'timeFrame': '30 days after heart transplantation', 'description': "ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)"}, {'measure': 'Health Questionnaires', 'timeFrame': '30 days after heart transplantation', 'description': "Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)"}, {'measure': 'Right heart catheter', 'timeFrame': '30 days after heart transplantation', 'description': 'Changes in right heart catheter before and after heart transplantation'}, {'measure': 'Blood gas analysis', 'timeFrame': '30 days after heart transplantation', 'description': 'Changes in blood gas analyses before and after heart transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep-Disordered Breathing', 'Heart Failure', 'Heart Transplantation'], 'conditions': ['Sleep Disordered Breathing Central', 'Heart Failure', 'Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '25242802', 'type': 'RESULT', 'citation': 'Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.'}, {'pmid': '27938912', 'type': 'RESULT', 'citation': 'Basic K, Fox H, Spiesshofer J, Bitter T, Horstkotte D, Oldenburg O. Improvements of central respiratory events, Cheyne-Stokes respiration and oxygenation in patients hospitalized for acute decompensated heart failure. Sleep Med. 2016 Nov-Dec;27-28:15-19. doi: 10.1016/j.sleep.2016.10.006. Epub 2016 Oct 28.'}, {'pmid': '26612581', 'type': 'RESULT', 'citation': 'Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.'}, {'pmid': '41306066', 'type': 'DERIVED', 'citation': 'Potratz M, Manukyan T, Schramm R, Costard-Jackle A, Fuchs U, Morshuis M, Guenther SPW, Rojas SV, Rudolph V, Gummert JF, Fox H. Nocturnal Hypoxemic Burden Predicts Mortality in Patients Awaiting Heart Transplantation. J Sleep Res. 2025 Nov 27:e70256. doi: 10.1111/jsr.70256. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.', 'detailedDescription': 'Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation, as this topic is hardly studied yet and previous reports suggest changes in the entity of sleep-disordered breathing through heart transplantation. The circumstances and the impact of sleep-disordered breathing or residuals in heart transplant patients is not well understood yet and will be subject of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'End-stage heart failure patients assigned and eligible for heart transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage heart failure patients assigned and eligible for heart transplantation\n\nExclusion Criteria:\n\n* heart failure patients not eligible for heart transplantation'}, 'identificationModule': {'nctId': 'NCT03026634', 'acronym': 'HTx-HDZ-SDB-1', 'briefTitle': 'Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Heart and Diabetes Center North-Rhine Westfalia'}, 'officialTitle': 'Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial', 'orgStudyIdInfo': {'id': 'PDSAP-HTX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sleep-disordered breathing', 'type': 'BEHAVIORAL', 'description': 'Prevalence and dynamic of sleep-disordered breathing after heart transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart and Diabetes Center North-Rhine Westfalia', 'class': 'OTHER'}, 'collaborators': [{'name': 'The German Heart Foundation', 'class': 'OTHER'}, {'name': 'Deutsche Stiftung für Herzforschung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'Henrik Fox, MD', 'investigatorAffiliation': 'Heart and Diabetes Center North-Rhine Westfalia'}}}}