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Recruiting NCT07595809

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

No phase Interventional Heart Failure With Reduced Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance Exercise, Dietary Intervention.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in skeletal muscle mass [Time frame: Baseline to 6 months]
Secondary outcome measures (4)
  • Change in quality of life [Time frame: Baseline to 6 months]
  • Change in exercise capacity [Time frame: Baseline to 6 months]
  • Change in echocardiographic parameters of diastolic function [Time frame: Baseline to 6 months]
  • Change in laboratory biomarkers [Time frame: Baseline to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Poland · 1 center
  • 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland — Zabrze

Identifiers

NCT: NCT07595809 · BNW/NWN/0052/KB1/29/I/23/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗