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Sarcopenia in Patients With Heart Failure

NCT06634316 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-06

No results posted yet for this 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

Conditions

Interventions

OTHER

Mediterranean diet

Mediterranean diet recommendations and daily physical exercise

DIETARY_SUPPLEMENT

Hypercaloric, hyperproteic oral nutritional supplement

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

DIETARY_SUPPLEMENT

Protein module

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

COMBINATION_PRODUCT

Vitamin D supplementation

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

COMBINATION_PRODUCT

Physical exercise

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

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634316 on ClinicalTrials.gov