Heart Failure With Reduced Ejection Fraction
Conditions
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.
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.
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skeletal muscle mass | Baseline to 6 months | Quantitative assessment of skeletal muscle mass change over the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Baseline to 6 months | Assessed using the Minnesota Living With Heart Failure Questionnaire. |
| Change in exercise capacity | Baseline to 6 months | Assessed by the 6-minute walk test. |
| Change in echocardiographic parameters of diastolic function | 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'). |
| Change in laboratory biomarkers | Baseline to 6 months | Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol, |
Countries
Poland
Outcome results
None listed