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RecruitingNCT07595809Updated May 19, 2026

Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction

An interventional study of Resistance Exercise and Dietary Intervention in Heart Failure With Reduced Ejection Fraction, sponsored by Medical University of Silesia. Recruiting at 1 site in Poland. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 years after the study started (first participant enrolled May 2023, registered May 2026).
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction

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03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 100 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Written obtained prior to participation Age >30 years Diagnosis of chronic heart failure, functional class I-III \<40%

Exclusion criteria

Exclusion Criteria:

functional class IV heart failure Potentially reversible cause of heart failure Estimated \<30 mL/min Severe anemia ( \<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

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Standard medical care
  • Experimental
    Resistance Exercise Training

    Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist.

    Behavioral: Resistance Exercise

  • Experimental
    Dietary Intervention

    Individualized 14-day meal plan based on the DASH diet with high-protein components.

    Behavioral: Dietary Intervention

  • Experimental
    Combined Dietary and Exercise Intervention

    Combination of dietary counseling and resistance exercise training as described above.

    Behavioral: Resistance Exercise · Behavioral: Dietary Intervention

Interventions

  • BehavioralResistance Exercise

    The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.

  • BehavioralDietary Intervention

    Individualized 14-day meal plan based on the DASH diet with high-protein components.

06

What researchers measure

Primary outcomes

  1. Change in skeletal muscle mass

    Quantitative assessment of skeletal muscle mass change over the study period.

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change in quality of life

    Assessed using the Minnesota Living With Heart Failure Questionnaire.

    Time frame: Baseline to 6 months

  2. Change in exercise capacity

    Assessed by the 6-minute walk test.

    Time frame: Baseline to 6 months

  3. 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').

    Time frame: Baseline to 6 months

  4. Change in laboratory biomarkers

    Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,

    Time frame: Baseline to 6 months

07

Study locations

1 of 1 sites recruiting
  • 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
    Zabrze, Silesian Voivodeship 41-800, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07595809
Responsible party
Andrzej Tomasik MD PhD FESC (Associate Professor, Medical University of Silesia) — Principal investigator
First posted
May 19, 2026
Start date
May 8, 2023
Primary completion
Jul 31, 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
May 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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