Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:17 PM
Study NCT ID:
NCT07472660
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Prevention Program After Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)', 'timeFrame': '12 months', 'description': 'Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent'}], 'secondaryOutcomes': [{'measure': 'Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)', 'timeFrame': '24 months', 'description': 'Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent'}, {'measure': 'all-cause mortality', 'timeFrame': '24 months', 'description': 'all-cause mortality, defined as number of deaths of any cause that occur during the course of study'}, {'measure': 'cardiovascular mortality', 'timeFrame': '24 months', 'description': 'cardiovascular mortality, defined as number of deaths of cardiovascular cause that occur during the course of study, in particular death due to heart failure, myocardial infarction, stroke, sudden cardiac death'}, {'measure': 'completeness of anticongestive medication', 'timeFrame': '24 months', 'description': 'completeness of anticongestive medication, defined as use (0 = no, 1 = yes) of the four drug groups for heart failure (1. Angiotensin-converting enzyme inhibitor or angiotensin-1 receptor antagonist or angiotensin-1 receptor antagonist in combination with neprylisin inhibitor, 2. Beta blocker, 3. mineralocorticoid receptor antagonist, 4. Sodium-glucose-linked transporter 2 inhibitor) on a scale of 0 to 4 (0 = no substance group is taken, 1 = one substance group is taken, 2 = two substance groups are taken, 3 = three substance groups are taken, 4 = four substance groups are taken)'}, {'measure': 'changes in ejection fraction', 'timeFrame': '24 months', 'description': 'changes in ejection fraction, defined as delta in the percentage of left-ventricular ejection fraction measured at randomisation, after 12 month and after 24 months (delta %)'}, {'measure': 'NTproBNP', 'timeFrame': '24 months', 'description': 'defined as delta in NTproBNP (N-terminal pro-brain natriuretic peptide)-levels measured in nanogram per litre (ng/l) between hospitalisation, 12 months and 24 months'}, {'measure': 'ferritin and transferrin levels', 'timeFrame': '24 months', 'description': 'defined as delta in ferritin-levels measured in microgram per litre (ug/l) and transferrin-levels measured in gram per litre (g/l) between hospitalisation, 12 months and 24 months'}, {'measure': '6-minute walking distance', 'timeFrame': '24 months', 'description': 'defined as delta in the distance (measured in meters) a patient can walk in a standardised 6-minute walking distance between hospitalisation, 12 months and 24 months'}, {'measure': 'relative maximum oxygen-consumption (peak VO2)', 'timeFrame': '24 months', 'description': 'defined als delta in the relative maximum oxygen-consumption (peak VO2, ml/min/kg) measured by standardised cardiopulmonary exercise test between hospitalisation, 12 months and 24 months'}, {'measure': 'NYHA class', 'timeFrame': '24 months', 'description': 'defined as delta in the New-York-Heart-Association (NYHA) class between randomisation, 12 months and 24 months, whereby NYHA-class is defined on a scale from 1 to 4: 1 (no limitation): Normal physical exertion causes no symptoms, 2 (mild limitation): No symptoms at rest, but symptoms occur during normal, more strenuous exertion (e.g., climbing stairs, 3 (significant limitation): No symptoms at rest, but symptoms occur even with light physical exertion (e.g., walking on level ground), 4 (severe limitation): Symptoms occur even at rest, bedridden possible.'}, {'measure': 'quality of life (points in KCCQ-12)', 'timeFrame': '24 months', 'description': 'quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent'}, {'measure': 'depression status (points in PHQ-9)', 'timeFrame': '24 months', 'description': 'defined as delta in the total score in the standardised PHQ-9-questionnaire that indicates the severity of depressive symptoms between hospitalisation, 12 months and 24 months. The total score ranges from 0 to 27 points. Higher scores correspond to more severe symptoms: 0-4: No to minimal symptoms, 5-9: Mild depression, 10-14: Moderate depression. 15-19: Severe depression. 20-27: Severe depression'}, {'measure': 'score for self-care in dealing with heart failure (EHFScBS)', 'timeFrame': '24 months', 'description': 'defined as delta in the total score in the standardised EHFScBS-questionnaire to measure the self-care behavior of patients with heart failure between hospitalisation, 12 months and 24 months. The questionnaire consists of 9 questions for self-care in dealing with heart failure that are answered on a Likert scale from 1 ("I completely agree") to 5 ("I completely disagree"). The sum of the 9 items results in a score between 9 and 45 points. A lower raw score indicates better self-care behavior (fewer problems in everyday life), while a higher raw score indicates poorer self-care behavior and greater deficits. The delta of total points between hospitalisation, 12 months and 24 months is measured.'}, {'measure': 'number of correct answers in the AHFKT questionnaire', 'timeFrame': '24 months', 'description': "defined as delta in the number of correct answers in the Atlanta Heart Failure Knowledge Test (AHFKT) questionnaire between hospitalisation, 12 months and 24 months. The Atlanta Heart Failure Knowledge Test is a valid tool for measuring patients' knowledge about their own chronic heart failure. It contains of 30 questions with the option of answering either yes or no or selecting one of four possible answers, with only one answer being correct in each case. 0 points indicates the worst/no knowledge of heart failure, while 30 points indicates the best knowledge of heart failure."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Heat Failure Intervention', 'Heart Failure Nurse', 'Web-based Prevention Program'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Introduction: Care for patients with heart failure (HF) often remains inadequate, even though a variety of treatment options exist. Guideline-based, multimodal therapy is rarely fully established, partly due to insufficient intersectoral cooperation and insufficient patient training. Heart failure nurses (HFN) as specialized non-medical personnel are intended to contribute to better patient care. E-learning and the use of mobile devices are modern options for training patients. However, previous studies in this regard only examined a few aspects of therapy and came to different results. The Intensive Prevention Program after decompensated Heart Failure (IPP-HF) will investigate if a one-year web-based and HFN-guided program for patients hospitalized due to congestive heart failure leads to a lower rate of re-hospitalization and an improvement in quality of life (QoL).\n\nStudy design: Patients hospitalized for decompensated HF will be prospectively enrolled and assigned to either a 12 months HFN-guided intensive prevention program or standard care. The prevention program will include patient training per e-learning, use of an app for HF, linking the patient to an interdisciplinary heart failure network and referral to heart sports groups or other specialists and will include regular monitoring for signs of (threatening) decompensation, medication, fitness and QoL. The combined primary study endpoint will comprise rehospitalization for decompensated HF and QoL after 1 year. Secondary endpoints will include mortality, completeness of anticongestive medication, changes in ejection fraction, NTproBNP, ferritin, transferrin, 6-minute walking distance, relative maximum oxygen-consumption (peak VO2), NYHA-class, depression status (PHQ-9) and knowledge about HF (AHFKT).\n\nConclusions :The randomized IPP-HF study will evaluate the effect of an web-based and HFN-guided prevention program on rehospitalization and QoL for patients hospitalized for decompensated heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalization due to symptomatic HF NYHA II-IV, defined according to valid international guidelines, including signs of congestion, ejection fraction ≤40%, elevated NTproBNP\n* Age 18 - 80 years\n* Life expectancy \\> 2 years\n* Access to internet, physical and mental ability and consent to participate in a HFN-guided web-based prevention program\n\nExclusion Criteria:\n\n* Persistent NYHA IV at discharge\n* Reversible cause of heart failure (such as tachycardiomyopathy, acute myocarditis, pacemaker-induced HF, etc.)\n* Ejection fraction \\>40% (HFmrEF, HFpEF)\n* Patient refusal or inability to give informed consent\n* Participation in another trial\n* Exercise limitations due to clinical conditions not related to HF, e.g. disabling orthopedic, rheumatological, hematooncological or neurological diseases (such as disabling stroke), severe lung diseases (such as COLD GOLD IV)\n* Any major non-cardiac condition that would adversely affect survival during the duration of the study, e.g. malignant comorbidities with prognosis \\< 2 years or other severe comorbidities (such as end-stage liver cirrhosis) with prognosis \\< 2 years\n* Inability to cooperate with the protocol, e.g. chronic active drug and/or alcohol abuse, severe mental disorders (such as dementia), deafness or severe language barrier (with no sufficient options for translation), inability to come to the study visits for endpoint assessment'}, 'identificationModule': {'nctId': 'NCT07472660', 'acronym': 'IPP-HF', 'briefTitle': 'Intensive Prevention Program After Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Herzzentrum Bremen'}, 'officialTitle': 'Intensive Prevention Program After Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'BIHKF-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive Prevention Programm (IPP)', 'description': 'Participants will get access to a web-based patient portal for self learning about heart failure', 'interventionNames': ['Other: Web-based patient portal for self learning about heart failure']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care (UC)', 'description': 'Participant will be treated usual care for heart failure'}], 'interventions': [{'name': 'Web-based patient portal for self learning about heart failure', 'type': 'OTHER', 'description': 'E-learning program: the patient receives personal access to a study-specific website that provides training content on the topic of heart failure. The individual training modules build on each other. Access to the modules is controlled via HFN: once a module has been completed and, if applicable, a learning assessment has been successfully passed (depending on the module), the HFN will unlock the next training content. The patient should complete the program in the first 6 months of the study (and recap in the second half of the year). The program focusses on deepening what was trained in hospital. Additionally, an on-site appointment, ideally with relatives, is organized for resuscitation training.\n\n\\- E-training program: in addition to the theoretical learning content, the website also features training videos that show training programs specially adapted for heart failure patients, enabling them to engage in regular, ideally daily, structured home training.', 'armGroupLabels': ['Intensive Prevention Programm (IPP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28277', 'city': 'Bremen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Harm Wienbergen', 'role': 'CONTACT', 'email': 'harm.wienbergen@gesundheitnord.de', 'phone': '+494218794059'}], 'facility': 'Bremen Institute for Heart- and Circulation Research', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}], 'centralContacts': [{'name': 'Stephan Ruehle', 'role': 'CONTACT', 'email': 'stephan.ruehle@gesundheitnord.de', 'phone': '+494218794684'}, {'name': 'Harm Wienbergen', 'role': 'CONTACT', 'email': 'harm.wienbergen@gesundheitnord.de', 'phone': '+494218794059'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herzzentrum Bremen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nationale Herzallianz (NHA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Bremen Institute for Heart- and Circulation Research', 'investigatorFullName': 'Dr. Harm Wienbergen', 'investigatorAffiliation': 'Herzzentrum Bremen'}}}}