Heart Failure With Reduced Ejection FractionNCT07595809
Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
A study testing Resistance Exercise and Dietary Intervention in people with Heart Failure With Reduced Ejection Fraction, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Resistance Exercise and Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 8 May 2023to Apr 2027
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to participation Age >30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction <40%
Who cannot join
- NYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate <30 mL/min Severe anemia (hemoglobin <9 g/dL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
Zabrze, Silesian Voivodeship, 41-800
Andrzej Tomasik PhD Andrzej Tomasik, +48 32 271 10 10, atomasik@sum.edu.pl
About this study
Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.
This randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.
- Being tested
- Resistance Exercise, Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
Dietary InterventionBehavioural
Individualized 14-day meal plan based on the DASH diet with high-protein components.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical care | No intervention | Not described |
| Resistance Exercise Training | Experimental | Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist. Receives: Behavioral: Resistance Exercise |
| Dietary Intervention | Experimental | Individualized 14-day meal plan based on the DASH diet with high-protein components. Receives: Behavioral: Dietary Intervention |
| Combined Dietary and Exercise Intervention | Experimental | Combination of dietary counseling and resistance exercise training as described above. Receives: Behavioral: Resistance Exercise; Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mass
Quantitative assessment of skeletal muscle mass change over the study period.
Measured: Baseline to 6 months
Secondary outcomes (4)
Change in quality of life
Assessed using the Minnesota Living With Heart Failure Questionnaire.
Measured: Baseline to 6 months
Change in exercise capacity
Assessed by the 6-minute walk test.
Measured: Baseline to 6 months
Change in echocardiographic parameters of diastolic function
Changes in left ventricular diastolic function assessed by transthoracic echocardiography, including early transmitral inflow velocity (E), the ratio of early to late transmitral inflow velocities (E/A), and early diastolic mitral annular velocity (e').
Measured: Baseline to 6 months
Change in laboratory biomarkers
Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start8 May 2023
- Primary completion31 Jul 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Tomasik MD PhD FESC, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595809
- Sponsor's protocol ID
- BNW/NWN/0052/KB1/29/I/23/25
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT07595809
- Acronym / sponsor ID
- BNW/NWN/0052/KB1/29/I/23/25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 May 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.
Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.
This randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard medical care | No intervention | – |
| Resistance Exercise Training | Experimental | Behavioral: Resistance ExerciseElastic resistance bands and structured exercise education provided by a medical rehabilitation specialist. |
| Dietary Intervention | Experimental | Behavioral: Dietary InterventionIndividualized 14-day meal plan based on the DASH diet with high-protein components. |
| Combined Dietary and Exercise Intervention | Experimental | Behavioral: Resistance Exercise, Behavioral: Dietary InterventionCombination of dietary counseling and resistance exercise training as described above. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent obtained prior to participation Age >30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction <40%
Key exclusion criteria (1 listed)
- NYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate <30 mL/min Severe anemia (hemoglobin <9 g/dL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis
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 |
|---|---|---|
| Resistance ExerciseThe exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist. | Behavioural | Combined Dietary and Exercise Intervention, Resistance Exercise Training |
| Dietary InterventionIndividualized 14-day meal plan based on the DASH diet with high-protein components. | Behavioural | Combined Dietary and Exercise Intervention, Dietary Intervention |
Primary outcome
Change in skeletal muscle mass
Time frame: Baseline to 6 months
Quantitative assessment of skeletal muscle mass change over the study period.
4 secondary outcomes
Change in quality of life
Time frame: Baseline to 6 months
Change in exercise capacity
Time frame: Baseline to 6 months
Change in echocardiographic parameters of diastolic function
Time frame: Baseline to 6 months
Change in laboratory biomarkers
Time frame: Baseline to 6 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 19 May 2026.
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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.
2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
Zabrze, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Dietary Intervention in people with Heart Failure With Reduced Ejection Fraction, run by Medical University of Silesia at 1 site in Poland.
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 1 inclusion and 1 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 19 May 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skeletal muscle mass (time frame: Baseline to 6 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 19 May 2026.