NCT07472660 Intensive Prevention Program After Decompensated Heart Failure
| NCT ID | NCT07472660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herzzentrum Bremen |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-10-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). Study 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). Conclusions :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.
Eligibility Criteria
Inclusion Criteria: * Hospitalization due to symptomatic HF NYHA II-IV, defined according to valid international guidelines, including signs of congestion, ejection fraction ≤40%, elevated NTproBNP * Age 18 - 80 years * Life expectancy \> 2 years * Access to internet, physical and mental ability and consent to participate in a HFN-guided web-based prevention program Exclusion Criteria: * Persistent NYHA IV at discharge * Reversible cause of heart failure (such as tachycardiomyopathy, acute myocarditis, pacemaker-induced HF, etc.) * Ejection fraction \>40% (HFmrEF, HFpEF) * Patient refusal or inability to give informed consent * Participation in another trial * 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) * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07472660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07472660 currently recruiting?
Yes, NCT07472660 is actively recruiting participants. Contact the research team at stephan.ruehle@gesundheitnord.de for enrollment information.
Where is the NCT07472660 trial being conducted?
This trial is being conducted at Bremen, Germany.
Who is sponsoring the NCT07472660 clinical trial?
NCT07472660 is sponsored by Herzzentrum Bremen. The trial plans to enroll 200 participants.
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