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

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT03409926
Collaborator
(none)
72
Enrollment
3
Locations
3
Arms
48.6
Anticipated Duration (Months)
24
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Acacia Gum
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Need for FibEr Addition in SympTomatic Heart Failure
Actual Study Start Date :
Sep 13, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Microcrystalline Cellulose (MCC) 10 grams/day

non-fermentable active control

Dietary Supplement: Acacia Gum
dietary supplement will be added to the participant's usual diet

Experimental: Acacia Gum 5 grams/day

fermentable dietary fiber

Dietary Supplement: Acacia Gum
dietary supplement will be added to the participant's usual diet

Experimental: Acacia Gum 10 grams/day

fermentable dietary fiber

Dietary Supplement: Acacia Gum
dietary supplement will be added to the participant's usual diet

Outcome Measures

Primary Outcome Measures

  1. NT-proBNP [12 weeks]

    change in NT-proBNP level

  2. ST2 [12 weeks]

    change in NT-proBNP level

Secondary Outcome Measures

  1. Composite Clinical Outcomes [12 weeks]

    All cause death, hospitalizations and emergency department visits

  2. Quality of Life [12 weeks]

    Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire

  3. NYHA Functional Class [12 weeks]

    Change in NYHA class treated as a categorical variable

  4. 6-Minute Walk Test [12 weeks]

    Change in 6-Minute Walk test

  5. Fecal Microbiome Characterization [Baseline, Week 6, Week 12]

    To examine the gut microbiome in a descriptive manner and characterize predominant species and those linked to Short Chain Fatty Acid production

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of CalgaryCalgaryAlbertaCanadaT2N 4Z6
2Royal Alexandra HospitalEdmontonAlbertaCanadaT5H 3V9
3Mazankowski Heart InstituteEdmontonAlbertaCanadaT6G 2B7

Sponsors and Collaborators

  • University of Alberta

Investigators

  • Principal Investigator: Justin Ezekowitz, MBBCh, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Justin Ezekowitz, Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier:
NCT03409926
Other Study ID Numbers:
  • Pro00078692
First Posted:
Jan 24, 2018
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Justin Ezekowitz, Professor of Medicine, University of Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021