Intensive Prevention Program After Decompensated Heart Failure
Recruiting · NCT07472660 · Interventional (participants receive a specific treatment) · Lead sponsor: Herzzentrum Bremen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Bremen Institute for Heart- and Circulation Research - Bremen, Germany