Sarcopenia in Patients With Heart Failure

Nutritional Management of Sarcopenia in Patients With Heart Failure

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Mediterranean diet; Combination product: Vitamin D supplementation; Combination product: Physical exercise; Dietary supplement: Hypercaloric, hyperproteic oral nutritional supplement; Dietary supplement: Protein module

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • IMIBIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mediterranean diet; Mediterranean diet and physical exercise	Other: Mediterranean diet; 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)
Experimental: Standard hypercaloric hyperproteic Oral supplement; Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise	Other: Mediterranean diet; 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); Dietary supplement: Hypercaloric, hyperproteic oral nutritional supplement; Hypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise
Experimental: Protein module; Protein module (10g/day) plus Mediterranean diet and physical exercise	Other: Mediterranean diet; 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); Dietary supplement: Protein module; Protein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Changes in muscle mass	6 months
Functionality	Changes in functionality determined by the up and go test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin	Changes in serum albumin levels (g/dl)	6 months
C-RP	Changes in serum C-RP (g/dl)	6 months

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Heart Diseases; Muscular Atrophy; Atrophy; Heart Failure; Sarcopenia; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: Insuficiencia cardiaca 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No