Sarcopenia in Patients With Heart Failure

Maimónides Biomedical Research Institute of Córdoba

Status: Active, not recruiting

Conditions: Sarcopenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06634316

Insuficiencia cardiaca 2

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Mediterranean diet

Active Comparator group

Description:

Mediterranean diet and physical exercise

Treatment:

Combination Product: Vitamin D supplementation

Other: Mediterranean diet

Combination Product: Physical exercise

Standard hypercaloric hyperproteic Oral supplement

Experimental group

Description:

Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise

Treatment:

Combination Product: Vitamin D supplementation

Dietary Supplement: Hypercaloric, hyperproteic oral nutritional supplement

Other: Mediterranean diet

Combination Product: Physical exercise

Protein module

Experimental group

Description:

Protein module (10g/day) plus Mediterranean diet and physical exercise

Treatment:

Combination Product: Vitamin D supplementation

Other: Mediterranean diet

Combination Product: Physical exercise

Dietary Supplement: Protein module