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NCT Number: NCT07472660

Intensive Prevention Program After Decompensated Heart Failure

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bremen Institute for Heart- and Circulation Research

Bremen, 28277, Germany

Location status: Recruiting

Location contact

Harm Wienbergen

CONTACT

[email protected]

+494218794059

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

    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

Secondary outcomes

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

    Time frame: 24 months

    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

  2. all-cause mortality

    Time frame: 24 months

    all-cause mortality, defined as number of deaths of any cause that occur during the course of study

  3. cardiovascular mortality

    Time frame: 24 months

    cardiovascular mortality, defined as number of deaths of cardiovascular cause that occur during the course of study, in particular death due to heart failure, myocardial infarction, stroke, sudden cardiac death

  4. completeness of anticongestive medication

    Time frame: 24 months

    completeness of anticongestive medication, defined as use (0 = no, 1 = yes) of the four drug groups for heart failure (1. Angiotensin-converting enzyme inhibitor or angiotensin-1 receptor antagonist or angiotensin-1 receptor antagonist in combination with neprylisin inhibitor, 2. Beta blocker, 3. mineralocorticoid receptor antagonist, 4. Sodium-glucose-linked transporter 2 inhibitor) on a scale of 0 to 4 (0 = no substance group is taken, 1 = one substance group is taken, 2 = two substance groups are taken, 3 = three substance groups are taken, 4 = four substance groups are taken)

  5. changes in ejection fraction

    Time frame: 24 months

    changes in ejection fraction, defined as delta in the percentage of left-ventricular ejection fraction measured at randomisation, after 12 month and after 24 months (delta %)

  6. NTproBNP

    Time frame: 24 months

    defined as delta in NTproBNP (N-terminal pro-brain natriuretic peptide)-levels measured in nanogram per litre (ng/l) between hospitalisation, 12 months and 24 months

  7. ferritin and transferrin levels

    Time frame: 24 months

    defined as delta in ferritin-levels measured in microgram per litre (ug/l) and transferrin-levels measured in gram per litre (g/l) between hospitalisation, 12 months and 24 months

  8. 6-minute walking distance

    Time frame: 24 months

    defined as delta in the distance (measured in meters) a patient can walk in a standardised 6-minute walking distance between hospitalisation, 12 months and 24 months

  9. relative maximum oxygen-consumption (peak VO2)

    Time frame: 24 months

    defined als delta in the relative maximum oxygen-consumption (peak VO2, ml/min/kg) measured by standardised cardiopulmonary exercise test between hospitalisation, 12 months and 24 months

  10. NYHA class

    Time frame: 24 months

    defined as delta in the New-York-Heart-Association (NYHA) class between randomisation, 12 months and 24 months, whereby NYHA-class is defined on a scale from 1 to 4: 1 (no limitation): Normal physical exertion causes no symptoms, 2 (mild limitation): No symptoms at rest, but symptoms occur during normal, more strenuous exertion (e.g., climbing stairs, 3 (significant limitation): No symptoms at rest, but symptoms occur even with light physical exertion (e.g., walking on level ground), 4 (severe limitation): Symptoms occur even at rest, bedridden possible.

  11. quality of life (points in KCCQ-12)

    Time frame: 24 months

    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. depression status (points in PHQ-9)

    Time frame: 24 months

    defined as delta in the total score in the standardised PHQ-9-questionnaire that indicates the severity of depressive symptoms between hospitalisation, 12 months and 24 months. The total score ranges from 0 to 27 points. Higher scores correspond to more severe symptoms: 0-4: No to minimal symptoms, 5-9: Mild depression, 10-14: Moderate depression. 15-19: Severe depression. 20-27: Severe depression

  13. score for self-care in dealing with heart failure (EHFScBS)

    Time frame: 24 months

    defined as delta in the total score in the standardised EHFScBS-questionnaire to measure the self-care behavior of patients with heart failure between hospitalisation, 12 months and 24 months. The questionnaire consists of 9 questions for self-care in dealing with heart failure that are answered on a Likert scale from 1 ("I completely agree") to 5 ("I completely disagree"). The sum of the 9 items results in a score between 9 and 45 points. A lower raw score indicates better self-care behavior (fewer problems in everyday life), while a higher raw score indicates poorer self-care behavior and greater deficits. The delta of total points between hospitalisation, 12 months and 24 months is measured.

  14. number of correct answers in the AHFKT questionnaire

    Time frame: 24 months

    defined as delta in the number of correct answers in the Atlanta Heart Failure Knowledge Test (AHFKT) questionnaire between hospitalisation, 12 months and 24 months. The Atlanta Heart Failure Knowledge Test is a valid tool for measuring patients' knowledge about their own chronic heart failure. It contains of 30 questions with the option of answering either yes or no or selecting one of four possible answers, with only one answer being correct in each case. 0 points indicates the worst/no knowledge of heart failure, while 30 points indicates the best knowledge of heart failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Harm Wienbergen

CONTACT

[email protected]

+494218794059

Stephan Ruehle

CONTACT

[email protected]

+494218794684

Sponsors and collaborators

Lead sponsor

Herzzentrum Bremen

Other

Collaborators

  • Nationale Herzallianz (NHA)

Registry information

Acronym: IPP-HF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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