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

November 20, 2022 updated by: Carolina Ortiz Cortes, Universidad de Extremadura

Prognostic and Clinical Impact of a Nutritional Intervention in Patients With Chronic Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcántara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Control arm: Who received the usual practice.
Other: standard practice
The patients received the usual treatment and clinical practice
EXPERIMENTAL: Intervention
Intervention arm: Who received an individualized diet, educational intervention with/without nutritional supplements depending on the degree of malnutrition plus usual practice
Other: standard practice
The patients received the usual treatment and clinical practice
Combination product: nutritional and educational intervention
individualized diet plus educational intervention with/without nutritional supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Time Frame: From randomisation until completion 365 days

[ 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the impact of the intervention on nutritional status.
Time Frame: baseline and 52 weeks
Nutritional status will be established according to the Mini Nutritional Assesment (MNA) score, which includes 18 items divided into 4 groups: anthropometry, general condition, dietary aspects and subjective assessment. The nutritional status is classified into 3 groups according to the score obtained: well nourished (equal to or greater than 24 points), at risk of malnutrition (17-23.5 points) and malnourished (less than 17 points), and other biochemical and anthropometric parameters will be collected to complete the nutritional study
baseline and 52 weeks
To assess the impact of the intervention on quality of life
Time Frame: baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52

Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52.

The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death.
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.
Time Frame: baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52
Functional capacity is assessed with the 6-minute test. It consists of measuring the maximum distance that the patient is able to walk in 6 minutes, in a short corridor, simultaneously evaluating the heart rate, oxygen saturation and the degree of dyspnea.
baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Investigators

  • Principal Investigator: Carolina Ortiz Cortés, Carolina Ortiz Cortés

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

November 1, 2022

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (ACTUAL)

September 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 20, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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