Intensive Prevention Program After Decompensated Heart Failure

Overview

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.

Interventions

• Other Web-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 (a

Primary outcome measures

• Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) [Time frame: 12 months]

Secondary outcome measures (12)

• Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) [Time frame: 24 months]
• all-cause mortality [Time frame: 24 months]
• cardiovascular mortality [Time frame: 24 months]
• completeness of anticongestive medication [Time frame: 24 months]
• changes in ejection fraction [Time frame: 24 months]
• NTproBNP [Time frame: 24 months]
• ferritin and transferrin levels [Time frame: 24 months]
• 6-minute walking distance [Time frame: 24 months]
• relative maximum oxygen-consumption (peak VO2) [Time frame: 24 months]
• NYHA class [Time frame: 24 months]
• quality of life (points in KCCQ-12) [Time frame: 24 months]
• depression status (points in PHQ-9) [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Germany · 1 center

• Bremen Institute for Heart- and Circulation Research — Bremen

Identifiers

NCT: NCT07472660 · BIHKF-4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗