Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06634316

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMIBIC

Córdoba, Cordoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean Diet

Other

Mediterranean diet recommendations and daily physical exercise

Hypercaloric, hyperproteic oral nutritional supplement

Dietary Supplement

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

Protein module

Dietary Supplement

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

Vitamin D supplementation

Combination Product

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

Physical exercise

Combination Product

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

Primary outcomes

  1. Muscle mass

    Time frame: 6 months

    Changes in muscle mass

  2. Functionality

    Time frame: 6 months

    Changes in functionality determined by the up and go test

Secondary outcomes

  1. Albumin

    Time frame: 6 months

    Changes in serum albumin levels (g/dl)

  2. C-RP

    Time frame: 6 months

    Changes in serum C-RP (g/dl)

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

Nutritional Management of Sarcopenia in Patients With Heart Failure

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.