Heart FailureIPP-HFNCT07472660
Intensive Prevention Program After Decompensated Heart Failure
A study testing Web-based patient portal for self learning about heart failure in people with Heart Failure, run by Herzzentrum Bremen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Web-based patient portal for self learning about heart failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Bremen Institute for Heart- and Circulation Research
Bremen, 28277
Harm Wienbergen, +494218794059, harm.wienbergen@gesundheitnord.de
About this study
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
- Being tested
- Web-based patient portal for self learning about heart failure
- Keywords
- Heart Failure, Heat Failure Intervention, Heart Failure Nurse, Web-based Prevention Program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based patient portal for self learning about heart failureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Prevention Programm (IPP) | Active comparator | Participants will get access to a web-based patient portal for self learning about heart failure Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (14)
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
Measured: 24 months
all-cause mortality
all-cause mortality, defined as number of deaths of any cause that occur during the course of study
Measured: 24 months
cardiovascular mortality
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
Measured: 24 months
completeness of anticongestive medication
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)
Measured: 24 months
changes in ejection fraction
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 %)
Measured: 24 months
NTproBNP
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
Measured: 24 months
ferritin and transferrin levels
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
Measured: 24 months
6-minute walking distance
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
Measured: 24 months
relative maximum oxygen-consumption (peak VO2)
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
Measured: 24 months
NYHA class
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.
Measured: 24 months
quality of life (points in KCCQ-12)
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
Measured: 24 months
depression status (points in PHQ-9)
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
Measured: 24 months
score for self-care in dealing with heart failure (EHFScBS)
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.
Measured: 24 months
number of correct answers in the AHFKT questionnaire
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Oct 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herzzentrum Bremen
- Sponsor type
- University, hospital or other
- Collaborators
- Nationale Herzallianz (NHA)
- Responsible party
- Principal investigator, Dr. Harm Wienbergen, Herzzentrum Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472660
- Sponsor's protocol ID
- BIHKF-4
- Acronym
- IPP-HF
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Prevention Program After Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07472660
- Acronym / sponsor ID
- IPP-HF / BIHKF-4
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Heat Failure Intervention, Heart Failure Nurse, Web-based Prevention Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Herzzentrum BremenUniversity, hospital or other
- Collaborators
- Nationale Herzallianz (NHA)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Prevention Programm (IPP) | Active comparator | Other: Web-based patient portal for self learning about heart failureParticipants will get access to a web-based patient portal for self learning about heart failure |
| Usual Care (UC) | No intervention | –Participant will be treated usual care for heart failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based patient portal for self learning about heart failureE-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. | Other | Intensive Prevention Programm (IPP) |
Primary outcome
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
14 secondary outcomes
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
score for self-care in dealing with heart failure (EHFScBS)
Time frame: 24 months
number of correct answers in the AHFKT questionnaire
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based patient portal for self learning about heart failure in people with Heart Failure, run by Herzzentrum Bremen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Ruehle (+494218794684, stephan.ruehle@gesundheitnord.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.