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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

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
03

Who can participate

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

Inclusion criteria

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%

Exclusion criteria

Exclusion Criteria:

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

04

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.

05

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

06

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
07

Registry details

Key details

Study ID
NCT07595809
Lead sponsor
Medical University of Silesia
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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