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The Need for FibEr Addition in SympTomatic Heart Failure (FEAST-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acacia Gum
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • Willing and able to provide informed consent
  • Patients with established Heart Failure (as per their treating physician) including those with both reduced and preserved ejection fraction

Exclusion Criteria:

  • Patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease)
  • Patients who do not control their own meals (e.g. meals-on-wheels, long-term care)
  • Patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)

Sites / Locations

  • University of Calgary
  • Royal Alexandra Hospital
  • Mazankowski Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Microcrystalline Cellulose (MCC) 10 grams/day

Acacia Gum 5 grams/day

Acacia Gum 10 grams/day

Arm Description

non-fermentable active control

fermentable dietary fiber

fermentable dietary fiber

Outcomes

Primary Outcome Measures

NT-proBNP
change in NT-proBNP level

Secondary Outcome Measures

Composite Clinical Outcomes
All cause death, hospitalizations and emergency department visits
Quality of Life
Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
NYHA Functional Class
Change in NYHA class treated as a categorical variable
6-Minute Walk Test
Change in 6-Minute Walk test
Fecal Microbiome Characterization
To examine the gut microbiome in a descriptive manner and characterize predominant species and those linked to Short Chain Fatty Acid production
ST-2
change in ST-2 level

Full Information

First Posted
January 18, 2018
Last Updated
August 16, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03409926
Brief Title
The Need for FibEr Addition in SympTomatic Heart Failure
Acronym
FEAST-HF
Official Title
The Need for FibEr Addition in SympTomatic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

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

5. Study Description

Brief Summary
FEAST-HF is a single-centre clinical trial in ambulatory patients with chronic HF to evaluate whether dietary supplementation with acacia gum reduces HF-related biomarkers NT-proBNP and ST2 and how the gut microbiome responds to dietary supplementation with acacia gum. The hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a reduction in NT-proBNP and ST2 in patients with HF after treatment with acacia gum, and 2) gut microbiome configurations (composition, diversity), stability and function (gene content) will be significantly altered in patients with HF in response to acacia gum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microcrystalline Cellulose (MCC) 10 grams/day
Arm Type
Active Comparator
Arm Description
non-fermentable active control
Arm Title
Acacia Gum 5 grams/day
Arm Type
Experimental
Arm Description
fermentable dietary fiber
Arm Title
Acacia Gum 10 grams/day
Arm Type
Experimental
Arm Description
fermentable dietary fiber
Intervention Type
Dietary Supplement
Intervention Name(s)
Acacia Gum
Intervention Description
dietary supplement will be added to the participant's usual diet
Primary Outcome Measure Information:
Title
NT-proBNP
Description
change in NT-proBNP level
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Composite Clinical Outcomes
Description
All cause death, hospitalizations and emergency department visits
Time Frame
12 weeks
Title
Quality of Life
Description
Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
Time Frame
12 weeks
Title
NYHA Functional Class
Description
Change in NYHA class treated as a categorical variable
Time Frame
12 weeks
Title
6-Minute Walk Test
Description
Change in 6-Minute Walk test
Time Frame
12 weeks
Title
Fecal Microbiome Characterization
Description
To examine the gut microbiome in a descriptive manner and characterize predominant species and those linked to Short Chain Fatty Acid production
Time Frame
Baseline, Week 6, Week 12
Title
ST-2
Description
change in ST-2 level
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Willing and able to provide informed consent Patients with established Heart Failure (as per their treating physician) including those with both reduced and preserved ejection fraction Exclusion Criteria: Patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease) Patients who do not control their own meals (e.g. meals-on-wheels, long-term care) Patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, MBBCh
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Mazankowski Heart Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Need for FibEr Addition in SympTomatic Heart Failure

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