RecruitingNot ApplicableNCT07472660

Intensive Prevention Program After Decompensated Heart Failure

Sponsor

Herzzentrum Bremen

Enrollment

200 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria8

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

Interventions

OTHERWeb-based patient portal for self learning about heart failure

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. \- 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.