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Clinical Trials in Spain / NCT06634316
Active, not recruiting Not applicable

Sarcopenia in Patients With Heart Failure

NCT06634316 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-11-15
Last updated
2025-05-06

Condition(s) studied

Sarcopenia

Investigational drug(s) / intervention(s)

Mediterranean dietHypercaloric, hyperproteic oral nutritional supplementProtein moduleVitamin D supplementationPhysical exercise

Mediterranean diet: Mediterranean diet recommendations and daily physical exercise

Hypercaloric, hyperproteic oral nutritional supplement: Hypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise

Protein module: Protein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise

Vitamin D supplementation: Calcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml)

Physical exercise: Physical exercise adapted to patients with heart failure (Cardiac rehabilitation)

Study summary

Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with a previous admission due to HF in the previous 12 months * Moderate or severe LVEF * Both sexs * Age \>18 years old. Exclusion Criteria: * MDRD \<15 ml/min * End-stage liver disease.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IMIBIC Córdoba Cordoba

More Maimónides Biomedical Research Institute of Córdoba trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06634316 on ClinicalTrials.gov ↗ ← All trials in Spain