Intensive Prevention Program After Decompensated Heart Failure

NCT07472660 | Recruiting DMC

• 1 other identifier: BIHKF-4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Heat Failure Intervention; Heart Failure Nurse; Web-based Prevention Program

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)

  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

  12 months

Secondary Outcomes (14)

• Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)

  24 months

• all-cause mortality

  24 months

• cardiovascular mortality

  24 months

• completeness of anticongestive medication

  24 months

• changes in ejection fraction

  24 months

Study Arms (2)

Intensive Prevention Programm (IPP)

ACTIVE COMPARATOR

Participants will get access to a web-based patient portal for self learning about heart failure

Other: Web-based patient portal for self learning about heart failure

Usual Care (UC)

NO INTERVENTION

Participant will be treated usual care for heart failure

Interventions

Web-based patient portal for self learning about heart failure OTHER

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.

Intensive Prevention Programm (IPP)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herzzentrum Bremen: lead
• Nationale Herzallianz (NHA): collaborator

Study Sites (1)

Bremen Institute for Heart- and Circulation Research

Bremen, 28277, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Stephan Ruehle

CONTACT

+494218794684; stephan.ruehle@gesundheitnord.de

Harm Wienbergen

CONTACT

+494218794059; harm.wienbergen@gesundheitnord.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Bremen Institute for Heart- and Circulation Research

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 16, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)