Chronic Heart FailurePhase 3HOMEX-HF-PNCT02051712
Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure
A Phase 3 study testing exercise training and Adherence measures in people with Chronic Heart Failure, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- exercise training and Adherence measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Dec 2024
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men
- age 30-75 years
- chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
- disease duration ≥ 6 month
- medical therapy accruing to guidelines (drug, devices, including CRT)
- written informed consent
Who cannot join
- acute myocarditis
- instable angina
- heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
- severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) < 6 weeks before study start
- preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
- uncorrected valve regurgitation or stenosis (> second degree)
Show all 10Show fewer
- safety concerns regarding or other reasons against exercise training
- severe depression
- regular exercise training within the last 6 weeks
- life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Marcus Dörr
Greifswald, 17475
Marcus Dörr, MD, +49 3834 8680500, mdoerr@uni-greifswald.de
Stephan B Felix, MD, +4938348680500, felix@uni-greifswald.de
About this study
Official title: Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.
- Conditions
- Chronic Heart Failure
- Being tested
- exercise training, Adherence measures
- Keywords
- chronic heart failure, exercise training, preferred training, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
individualized exercise training
Adherence measuresBehavioural
Measures to increase adherence to exercise training
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual car accruing to guidelines |
| Individualized training | Experimental | Individualized exercise training program in addition to usual care Receives: Behavioral: exercise training |
| Individualized training plus adherence measures | Experimental | Individualized exercise training plus measures to increase adherence Receives: Behavioral: exercise training; Behavioral: Adherence measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2@AT
Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs)
Measured: Month 9
Secondary outcomes (1)
Training adherence
Adherence to training sessions
Measured: 9, 12, 18 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Marcus Dörr, MD, Principal investigator, University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051712
- Sponsor's protocol ID
- DZHK-HGW-001
- Acronym
- HOMEX-HF-P
- Status last verified
- Dec 2023
- First submitted
- 29 Jan 2014
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
- ClinicalTrials.gov ID
- NCT02051712
- Acronym / sponsor ID
- HOMEX-HF-P / DZHK-HGW-001
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, exercise training, preferred training, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Feb 2014
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2014 (estimated)
- 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.
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual car accruing to guidelines |
| Individualized training | Experimental | Behavioral: exercise trainingIndividualized exercise training program in addition to usual care |
| Individualized training plus adherence measures | Experimental | Behavioral: exercise training, Behavioral: Adherence measuresIndividualized exercise training plus measures to increase adherence |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women and men
- age 30-75 years
- chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
- disease duration ≥ 6 month
- medical therapy accruing to guidelines (drug, devices, including CRT)
Key exclusion criteria (10 listed)
- acute myocarditis
- instable angina
- heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
- severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) < 6 weeks before study start
- preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
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 trainingindividualized exercise training | Behavioural | Individualized training, Individualized training plus adherence measures |
| Adherence measuresMeasures to increase adherence to exercise training | Behavioural | Individualized training plus adherence measures |
Primary outcome
VO2@AT
Time frame: Month 9
Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs)
1 secondary outcome
Training adherence
Time frame: 9, 12, 18 and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Marcus Dörr, MD principal investigator
University Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise training and Adherence measures in people with Chronic Heart Failure, run by University Medicine Greifswald 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 6 inclusion and 10 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 12 Dec 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marcus Dörr, MD (+49 3834 8680500, mdoerr@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2@AT (time frame: Month 9). 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 12 Dec 2023.