Sarcopenia in Patients With Heart Failure

NCT06634316 | Active Not Recruiting

• 1 other identifier: Insuficiencia cardiaca 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Muscle mass

  Changes in muscle mass

  6 months

• Functionality

  Changes in functionality determined by the up and go test

  6 months

Secondary Outcomes (2)

• Albumin

  6 months

• C-RP

  6 months

Study Arms (3)

Mediterranean diet

ACTIVE COMPARATOR

Mediterranean diet and physical exercise

Other: Mediterranean diet; Combination Product: Vitamin D supplementation; Combination Product: Physical exercise

Standard hypercaloric hyperproteic Oral supplement

EXPERIMENTAL

Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise

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

Protein module

EXPERIMENTAL

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

Other: Mediterranean diet; Dietary Supplement: Protein module; Combination Product: Vitamin D supplementation; Combination Product: Physical exercise

Interventions

Mediterranean diet OTHER

Mediterranean diet recommendations and daily physical exercise

Mediterranean diet; Protein module; Standard hypercaloric hyperproteic Oral supplement

Hypercaloric, hyperproteic oral nutritional supplement DIETARY_SUPPLEMENT

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

Standard hypercaloric hyperproteic Oral supplement

Protein module DIETARY_SUPPLEMENT

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

Protein module

Vitamin D supplementation COMBINATION_PRODUCT

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

Mediterranean diet; Protein module; Standard hypercaloric hyperproteic Oral supplement

Physical exercise COMBINATION_PRODUCT

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

Mediterranean diet; Protein module; Standard hypercaloric hyperproteic Oral supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a previous admission due to HF in the previous 12 months
• Moderate or severe LVEF
• Both sexs
• Age \>18 years old.

You may not qualify if:

• MDRD \<15 ml/min
• End-stage liver disease.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

IMIBIC

Córdoba, Cordoba, 14004, Spain

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Diet, Mediterranean; Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 9, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

ES (1)