Sarcopenia in Patients With Heart Failure

Not Applicable

Active, not recruiting

• Conditions: Sarcopenia
• Interventions: Other: Mediterranean diet; Combination Product: Vitamin D supplementation; Dietary Supplement: Hypercaloric, hyperproteic oral nutritional supplement; Dietary Supplement: Protein module; Combination Product: Physical exercise

• Registration Number: NCT06634316
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-09
• Study Start: 2024-11-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	Mediterranean diet	Mediterranean diet and physical exercise
Mediterranean diet	Vitamin D supplementation	Mediterranean diet and physical exercise
Mediterranean diet	Physical exercise	Mediterranean diet and physical exercise
Standard hypercaloric hyperproteic Oral supplement	Mediterranean diet	Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise
Standard hypercaloric hyperproteic Oral supplement	Hypercaloric, hyperproteic oral nutritional supplement	Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise
Standard hypercaloric hyperproteic Oral supplement	Vitamin D supplementation	Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise
Standard hypercaloric hyperproteic Oral supplement	Physical exercise	Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise
Protein module	Mediterranean diet	Protein module (10g/day) plus Mediterranean diet and physical exercise
Protein module	Protein module	Protein module (10g/day) plus Mediterranean diet and physical exercise
Protein module	Vitamin D supplementation	Protein module (10g/day) plus Mediterranean diet and physical exercise
Protein module	Physical exercise	Protein module (10g/day) plus Mediterranean diet and physical exercise

Primary Outcome Measures

Name	Time	Method
Muscle mass	6 months	Changes in muscle mass
Functionality	6 months	Changes in functionality determined by the up and go test

Secondary Outcome Measures

Name	Time	Method
Albumin	6 months	Changes in serum albumin levels (g/dl)
C-RP	6 months	Changes in serum C-RP (g/dl)

Trial Locations

Locations (1)

IMIBIC; 🇪🇸 Cordoba, Spain