NCT05923138

Brief Summary

This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure. Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 9, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

June 9, 2023

Last Update Submit

November 21, 2023

Conditions

Heart Failure

Keywords

HEART FAILUREMALNUTRITION

Outcome Measures

Primary Outcomes (1)

  • COMBINED EVENT

    Time to the combined event of all-cause mortality or admission for heart failure at 6 months

    6 MONTHS

Secondary Outcomes (4)

  • Time to 6-month cardiovascular mortality

    6 MONTHS

  • Time to all-cause admission at 6 months

    6 MONTHS

  • Changes in quality of life at 3 and 6 months post-intervention

    6 MONTHS

  • Changes in nutritional status at 3 and 6 months post intervention

    6 MONTHS

Study Arms (2)

NUTRITIONAL INTERVENTION

EXPERIMENTAL
Dietary Supplement: MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS

CONTROL

PLACEBO COMPARATOR
Dietary Supplement: CONTROL

Interventions

MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTSDIETARY_SUPPLEMENT

Nutritional intervention (diet, dietetic recommendations and/or supplements). Participants will receive specific recommendations about diet, energetic dietetic supplementation, oral nutritional supplements, exercise... The "Nutrition Team" (formed by cardiologists, dieticians, nurses...) will closely monitor patients with periodic visits and reassessment of nutritional status and compliance with recommendations.

Also known as: NUTRITION TEAM
NUTRITIONAL INTERVENTION
CONTROLDIETARY_SUPPLEMENT

Standard treatment (usual recommendations in patients with heart failure)

CONTROL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients older than 65 years with malnutrition (MNA-SF score ≤ 11) with chronic ambulatory heart failure (HF).

You may not qualify if:

  • Admission for heart failure (HF) in the last month,
  • Chronic renal failure on dialysis.
  • Patients already on nutritional treatment.
  • Concomitant diseases which, apart from the HF itself, could lead to a life expectancy of less than 1 year,
  • Patients included in other clinical trials.
  • Patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose.
  • Patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute HF,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Burgos

Burgos, Spain

RECRUITING

MeSH Terms

Conditions

Heart FailureMalnutrition

Interventions

ExerciseDietary Supplements

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

JOSE ANGEL PEREZ-RIVERA

CONTACT

+34947281800JANGEL.PEREZRIVERA@GMAIL.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 28, 2023

Study Start

November 2, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)