NCT05527522

Brief Summary

Malnutrition is common in patients with heart failure (HF) and is associated with a worse prognosis. However, there is little information on the impact of nutritional intervention in malnourished patients with heart failure. Therefore, the aim of our study is to evaluate whether a specific nutritional intervention has an impact on mortality and hospitalizations, quality of life, nutritional status, and functional capacity in patient with heart failure and malnutrition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable heart-failure

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

August 30, 2022

Last Update Submit

November 20, 2022

Conditions

Heart FailureMalnutrition

Keywords

MalnutritionHeart failureNutritional intervention

Outcome Measures

Primary Outcomes (1)

  • Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)

    \[ Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier. Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    From randomisation until completion 365 days

Secondary Outcomes (3)

  • To assess the impact of the intervention on nutritional status.

    baseline and 52 weeks

  • To assess the impact of the intervention on quality of life

    baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52

  • To assess the impact of the intervention on be assessed by means of the 6-minute test.

    baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52

Study Arms (2)

Control

PLACEBO COMPARATOR

Control arm: Who received the usual practice.

Other: standard practice

Intervention

EXPERIMENTAL

Intervention arm: Who received an individualized diet, educational intervention with/without nutritional supplements depending on the degree of malnutrition plus usual practice

Combination Product: nutritional and educational interventionOther: standard practice

Interventions

nutritional and educational interventionCOMBINATION_PRODUCT

individualized diet plus educational intervention with/without nutritional supplements

Intervention
standard practiceOTHER

The patients received the usual treatment and clinical practice

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years with a confirmed diagnosis of HF according to current criteria established by clinical practice guidelines and who present left ventricular dysfunction documented by echocardiography (LVEF less than 40%).
  • Patients with clinical stability in the last 6 months defined as no admissions or decompensations in the last 6 months.
  • Patients with malnutrition or at risk of malnutrition according to criteria established by the Mini Nutritional Assessment score (see attached).
  • Patients who agree to participate in the study by signing the written informed consent after receiving verbal and written information about the study.

You may not qualify if:

  • \*Dementia or severe cognitive impairment.
  • Dialysis.
  • Already receiving nutritional supplements.
  • Known concomitant oncologic process or other concomitant disease with life expectancy of less than 1 year.
  • Pregnant women.
  • Participation in another clinical trial concurrently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Heart FailureMalnutrition

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Carolina Ortiz Cortés

    Carolina Ortiz Cortés

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 2, 2022

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion

November 1, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

ES(1)