Nutritional Intervention in Malnourished Patients With Chronic Heart Failure (PACMAN-HF)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    86
  • sponsor
    Universidad de Extremadura
Updated on 7 October 2022
heart failure
chronic heart failure
left ventricular dysfunction

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.

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.

Details
Condition Heart Failure, Malnutrition
Treatment Standard Practice, nutritional and educational intervention
Clinical Study IdentifierNCT05527522
SponsorUniversidad de Extremadura
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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