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

Universidad de Extremadura

Status: Completed

Conditions: Malnutrition; Heart Failure

Treatments: Other: standard practice; Combination Product: nutritional and educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05527522

3/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control arm: Who received the usual practice.

Treatment:

Other: standard practice

Intervention

Experimental group

Description:

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

Treatment:

Combination Product: nutritional and educational intervention

Other: standard practice