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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Behavioral: Resistance Exercise; Behavioral: Dietary Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Silesian Voivodeship
    • Zabrze, Silesian Voivodeship, Poland, 41-800
      • Recruiting
      • 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
      • Contact: Andrzej Tomasik PhD Andrzej Tomasik; Phone Number: +48 32 271 10 10; Email: atomasik@sum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
Experimental: Dietary Intervention; Individualized 14-day meal plan based on the DASH diet with high-protein components.	Behavioral: Dietary Intervention; Individualized 14-day meal plan based on the DASH diet with high-protein components.
Experimental: Combined Dietary and Exercise Intervention; Combination of dietary counseling and resistance exercise training as described above.	Behavioral: Resistance Exercise; The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.; Behavioral: Dietary Intervention; Individualized 14-day meal plan based on the DASH diet with high-protein components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skeletal muscle mass	Quantitative assessment of skeletal muscle mass change over the study period.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Assessed using the Minnesota Living With Heart Failure Questionnaire.	Baseline to 6 months
Change in exercise capacity	Assessed by the 6-minute walk test.	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').	Baseline to 6 months
Change in laboratory biomarkers	Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Nutrition Therapy; Physical Conditioning, Human; Exercise; Resistance Training; Diet Therapy
• Other Study ID Numbers: BNW/NWN/0052/KB1/29/I/23/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No