Heart FailureNCT04696900
Effect of Prescribed Cardiac Rehabilitation in Patients With Advanced Heart Failure or Ventricular Assist Device
A study testing Exercise training in people with Heart Failure, run by German Heart Institute at 1 site in Germany.
Trial summary
This trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >17 years
- written informed consent
- chronic end-stage systolic heart failure with or without ventricular assist device
- clinically stable for at least 6 weeks
- prescription of cardiac rehabilitation
Who cannot join
- addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
- lack of knowledge of German to fully understand study information
- pregnancy, pre-menopausal women
- participation in the rehabilitation program < 80%
- contraindications of cardiopulmonary exercise testing on an ergometer
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Institute
Berlin, 13353
I A Just, 00493045932025, ijust@dhzb.de
F Schoenrath, 00493045932085, schoenrath@dhzb.de
About this study
Official title: Examination of the Effect of Prescribed Cardiac Rehabilitation on Quality of Life, Exercise Capacity and Course of Disease in Patients With Advanced Heart Failure or After Ventricular Assist Device Implantation
This trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. Furthermore, clinical, laboratory and echocardiographic markers of heart failure, rehospitalization rates and cost-effectiveness will be assessed.
- Conditions
- Heart Failure
- Being tested
- Exercise training
- Keywords
- advanced heart failure, ventricular assist device, exercise training, cardiac rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingProcedure or surgery
exercise training in an approved rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Other | 14 participants will absolve a prescribed exercise training for 12 months. Receives: Procedure: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of exercise training in severe heart failure as assessed by quality of life
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
Measured: after 3, 6 and 12 months
Efficacy of exercise training in severe heart failure as assessed by exercise capacity
Change of exercise capacity measured by six-minute walking distance in meters
Measured: after 3, 6 and 12 months
Secondary outcomes (10)
rehospitalization rates
Change in rehospitalization rate or unplanned outpatient healthcare visits due to symptoms of heart failure measured by a final visit and record screening
Measured: 12 months before training and 12 months while training
heart failure biomarkers
Change in biomarkers of heart failure: NTproBNP
Measured: after 6 and 12 months
Renal function biomarker: Creatinin
Change in biomarkers of renal function: creatinin
Measured: after 6 and 12 months
Renal function biomarkers: glomerular Filtration rate
Change in biomarkers of renal function: glomerular filtration rate
Measured: after 6 and 12 months
Hepatic function biomarkers: transaminases
Change in biomarkers of hepatic function: transaminases
Measured: after 6 and 12 months
Hepatic function biomarkers: gamma-glutamyltransferase
Change in biomarkers of hepatic function: gamma-glutamyltransferase
Measured: after 6 and 12 months
Heart failure Progression: Ejection fractions
Change of echocardiographic findings: ejection fraction (in %)
Measured: after 6 and 12 months
Heart failure Progression: Diameters
Change of echocardiographic findings: diameters (in mm)
Measured: after 6 and 12 months
Heart failure Progression: Aortic Valve opening
Change of echocardiographic findings: aortic valve opening
Measured: after 6 and 12 months
Heart failure Progression: Valvular regurgitations
Change of echocardiographic findings: Valvular regurgitation (in grades I-III°)
Measured: after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jun 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I A Just, Principal investigator, German Heart InstituteF Schoenrath, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696900
- Sponsor's protocol ID
- REHAB-HF/VAD
- Status last verified
- Dec 2020
- First submitted
- 4 Feb 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effect of Prescribed Cardiac Rehabilitation on Quality of Life, Exercise Capacity and Course of Disease in Patients With Advanced Heart Failure or After Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT04696900
- Acronym / sponsor ID
- REHAB-HF/VAD
- Conditions
- Heart Failure
- Keywords
- advanced heart failure, ventricular assist device, exercise training, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jan 2021 (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.
This trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. Furthermore, clinical, laboratory and echocardiographic markers of heart failure, rehospitalization rates and cost-effectiveness will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Other | Procedure: Exercise training14 participants will absolve a prescribed exercise training for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >17 years
- written informed consent
- chronic end-stage systolic heart failure with or without ventricular assist device
- clinically stable for at least 6 weeks
- prescription of cardiac rehabilitation
Key exclusion criteria (5 listed)
- addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
- lack of knowledge of German to fully understand study information
- pregnancy, pre-menopausal women
- participation in the rehabilitation program < 80%
- contraindications of cardiopulmonary exercise testing on an ergometer
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 |
|---|---|---|
| Exercise trainingexercise training in an approved rehabilitation program | Procedure or surgery | Exercise training |
Primary outcome
Efficacy of exercise training in severe heart failure as assessed by quality of life
Time frame: after 3, 6 and 12 months
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
Efficacy of exercise training in severe heart failure as assessed by exercise capacity
Time frame: after 3, 6 and 12 months
Change of exercise capacity measured by six-minute walking distance in meters
10 secondary outcomes
rehospitalization rates
Time frame: 12 months before training and 12 months while training
heart failure biomarkers
Time frame: after 6 and 12 months
Renal function biomarker: Creatinin
Time frame: after 6 and 12 months
Renal function biomarkers: glomerular Filtration rate
Time frame: after 6 and 12 months
Hepatic function biomarkers: transaminases
Time frame: after 6 and 12 months
Hepatic function biomarkers: gamma-glutamyltransferase
Time frame: after 6 and 12 months
Heart failure Progression: Ejection fractions
Time frame: after 6 and 12 months
Heart failure Progression: Diameters
Time frame: after 6 and 12 months
Heart failure Progression: Aortic Valve opening
Time frame: after 6 and 12 months
Heart failure Progression: Valvular regurgitations
Time frame: after 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Active, not recruiting
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Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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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. This study is not recruiting at the moment.
I A Just principal investigator
German Heart Institute
F Schoenrath principal investigator
German Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Heart Failure, run by German Heart Institute 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I A Just (00493045932025, ijust@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of exercise training in severe heart failure as assessed by quality of life (time frame: after 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 19 Nov 2021.