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

Primary Purpose

Heart Failure, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
nutritional and educational intervention
standard practice
Sponsored by
Universidad de Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Malnutrition, Heart failure, Nutritional intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital San Pedro de Alcántara

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Control arm: Who received the usual practice.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the impact of the intervention on nutritional status.
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
To assess the impact of the intervention on quality of life
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.
To assess the impact of the intervention on be assessed by means of the 6-minute test.
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.

Full Information

First Posted
August 30, 2022
Last Updated
November 20, 2022
Sponsor
Universidad de Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT05527522
Brief Title
Nutritional Intervention in Malnourished Patients With Chronic Heart Failure
Acronym
PACMAN-HF
Official Title
Prognostic and Clinical Impact of a Nutritional Intervention in Patients With Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Malnutrition
Keywords
Malnutrition, Heart failure, Nutritional intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control arm: Who received the usual practice.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention arm: Who received an individualized diet, educational intervention with/without nutritional supplements depending on the degree of malnutrition plus usual practice
Intervention Type
Combination Product
Intervention Name(s)
nutritional and educational intervention
Intervention Description
individualized diet plus educational intervention with/without nutritional supplements
Intervention Type
Other
Intervention Name(s)
standard practice
Intervention Description
The patients received the usual treatment and clinical practice
Primary Outcome Measure Information:
Title
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Description
[ 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.
Time Frame
From randomisation until completion 365 days
Secondary Outcome Measure Information:
Title
To assess the impact of the intervention on nutritional status.
Description
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
Time Frame
baseline and 52 weeks
Title
To assess the impact of the intervention on quality of life
Description
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.
Time Frame
baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52
Title
To assess the impact of the intervention on be assessed by means of the 6-minute test.
Description
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.
Time Frame
baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Ortiz Cortés
Organizational Affiliation
Carolina Ortiz Cortés
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain

12. IPD Sharing Statement

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Nutritional Intervention in Malnourished Patients With Chronic Heart Failure

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