Nutritional Intervention in Malnourished Patients With Chronic Heart Failure

NCT ID: NCT05527522

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-11-01

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.

Detailed Description

A high prevalence of malnutrition has been reported in hospitalized patients with acute heart failure and some studies suggest that personalized treatments or interventions on nutritional status could improve prognosis in these patients. Previous studies have shown that malnutrition is an independent factor associated with worse prognosis not only in hospitalized patients with decompensated HF but also in patients with chronic stable HF. In this sense, it has been postulated that nutritional intervention in malnourished patients with HF could have some prognostic benefit. However, there are very few data published in the literature that have assessed the nutritional status and the benefit of a nutritional intervention in stable ambulatory patients with chronic HF.

Therefore, the aim of this study was to evaluate whether the application of an educational and nutritional intervention in malnourished patients with heart failure improves prognosis, nutritional status, functional capacity and quality of life.

Conditions

Heart Failure; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Control arm: Who received the usual practice.

Group Type: PLACEBO_COMPARATOR

standard practice

Intervention Type: OTHER

The patients received the usual treatment and clinical practice

Intervention

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

Group Type: EXPERIMENTAL

nutritional and educational intervention

Intervention Type: COMBINATION_PRODUCT

individualized diet plus educational intervention with/without nutritional supplements

standard practice

Intervention Type: OTHER

The patients received the usual treatment and clinical practice

Interventions

nutritional and educational intervention

individualized diet plus educational intervention with/without nutritional supplements

Intervention Type: COMBINATION_PRODUCT

standard practice

The patients received the usual treatment and clinical practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• *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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Carolina Ortiz Cortes

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina Ortiz Cortés

Role: PRINCIPAL_INVESTIGATOR

Carolina Ortiz Cortés

Locations

Hospital San Pedro de Alcántara

Cáceres, , Spain

Countries

Spain

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

3/2018

Identifier Type: -

Identifier Source: org_study_id