Sarcopenia in Patients With Heart Failure

NCT ID: NCT06634316

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mediterranean diet

Mediterranean diet and physical exercise

Group Type ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type OTHER

Mediterranean diet recommendations and daily physical exercise

Vitamin D supplementation

Intervention Type COMBINATION_PRODUCT

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

Physical exercise

Intervention Type COMBINATION_PRODUCT

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

Standard hypercaloric hyperproteic Oral supplement

Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise

Group Type EXPERIMENTAL

Mediterranean diet

Intervention Type OTHER

Mediterranean diet recommendations and daily physical exercise

Hypercaloric, hyperproteic oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin D supplementation

Intervention Type COMBINATION_PRODUCT

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

Physical exercise

Intervention Type COMBINATION_PRODUCT

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

Protein module

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

Group Type EXPERIMENTAL

Mediterranean diet

Intervention Type OTHER

Mediterranean diet recommendations and daily physical exercise

Protein module

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin D supplementation

Intervention Type COMBINATION_PRODUCT

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

Physical exercise

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Mediterranean diet

Mediterranean diet recommendations and daily physical exercise

Intervention Type OTHER

Hypercaloric, hyperproteic oral nutritional supplement

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

Intervention Type DIETARY_SUPPLEMENT

Protein module

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplementation

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

Intervention Type COMBINATION_PRODUCT

Physical exercise

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IMIBIC

Córdoba, Cordoba, Spain

Site Status

Countries

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Spain

Other Identifiers

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Insuficiencia cardiaca 2

Identifier Type: -

Identifier Source: org_study_id

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