NCT06634316

Sarcopenia in Patients With Heart Failure

Nutritional Management of Sarcopenia in Patients With Heart Failure

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Sarcopenia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-10-09
• Last updated: 2025-05-06

Locations

1 site across 1 country: Spain