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

NCT07595809 | Recruiting

• 1 other identifier: BNW/NWN/0052/KB1/29/I/23/25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Change in skeletal muscle mass

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

  Baseline to 6 months

Secondary Outcomes (4)

• Change in quality of life

  Baseline to 6 months

• Change in exercise capacity

  Baseline to 6 months

• Change in echocardiographic parameters of diastolic function

  Baseline to 6 months

• Change in laboratory biomarkers

  Baseline to 6 months

Study Arms (4)

Standard medical care

NO INTERVENTION

Resistance Exercise Training

EXPERIMENTAL

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

Behavioral: Resistance Exercise

Dietary Intervention

EXPERIMENTAL

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

Behavioral: Dietary Intervention

Combined Dietary and Exercise Intervention

EXPERIMENTAL

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

Behavioral: Resistance Exercise; Behavioral: Dietary Intervention

Interventions

Resistance Exercise BEHAVIORAL

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

Combined Dietary and Exercise Intervention; Resistance Exercise Training

Dietary Intervention BEHAVIORAL

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

Combined Dietary and Exercise Intervention; Dietary Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

MeSH Terms

Interventions

Resistance Training; Diet Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 8, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

PL (1)