NCT05848960

Brief Summary

Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

April 17, 2023

Last Update Submit

May 5, 2025

Conditions

Sarcopenia

Keywords

Heart failureSarcopeniaNutritional support

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    Changes in percent of muscle mass

    6 months

  • Left ventricular ejection fraction

    Changes in left ventricular ejection fraction

    6 months

Secondary Outcomes (7)

  • pro-BNP

    6 months

  • Fat mass

    6 months

  • Phase angle

    6 months

  • Albumin

    6 months

  • Preallbumin

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Mediterranean diet

ACTIVE COMPARATOR

Mediterranean diet

Other: Mediterranean diet

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

EXPERIMENTAL

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

Dietary Supplement: Hypercaloric, hyperproteic oral supplementOther: Mediterranean diet

Interventions

Hypercaloric, hyperproteic oral supplementDIETARY_SUPPLEMENT

2 supplements per day

Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Mediterranean dietOTHER

Mediterranean diet

Mediterranean dietMediterranean diet plus hypercaloric, hyperproteic oral supplement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIBIC

Córdoba, Cordoba, 14004, Spain

Location

MeSH Terms

Conditions

SarcopeniaHeart Failure

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 8, 2023

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 30, 2023

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)