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NCT Number: NCT07595809

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland

Zabrze, Silesian Voivodeship, 41-800, Poland

Location status: Recruiting

Location contact

Andrzej Tomasik PhD Andrzej Tomasik

CONTACT

[email protected]

+48 32 271 10 10

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Resistance exercise

Behavioral

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

Dietary intervention

Behavioral

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

Primary outcomes

  1. Change in skeletal muscle mass

    Time frame: Baseline to 6 months

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

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline to 6 months

    Assessed using the Minnesota Living With Heart Failure Questionnaire.

  2. Change in exercise capacity

    Time frame: Baseline to 6 months

    Assessed by the 6-minute walk test.

  3. Change in echocardiographic parameters of diastolic function

    Time frame: Baseline to 6 months

    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').

  4. Change in laboratory biomarkers

    Time frame: Baseline to 6 months

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

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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