The Need for FibEr Addition in SympTomatic Heart Failure

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 10, 2022

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Microcrystalline Cellulose (MCC) 10 grams/day
    • non-fermentable active control
  • Experimental: Acacia Gum 5 grams/day
    • fermentable dietary fiber
  • Experimental: Acacia Gum 10 grams/day
    • fermentable dietary fiber

Clinical Trial Outcome Measures

Primary Measures

  • NT-proBNP
    • Time Frame: 12 weeks
    • change in NT-proBNP level

Secondary Measures

  • Composite Clinical Outcomes
    • Time Frame: 12 weeks
    • All cause death, hospitalizations and emergency department visits
  • Quality of Life
    • Time Frame: 12 weeks
    • Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
  • NYHA Functional Class
    • Time Frame: 12 weeks
    • Change in NYHA class treated as a categorical variable
  • 6-Minute Walk Test
    • Time Frame: 12 weeks
    • Change in 6-Minute Walk test
  • Fecal Microbiome Characterization
    • Time Frame: 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
  • ST-2
    • Time Frame: 12 weeks
    • change in ST-2 level

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Justin Ezekowitz, Professor of Medicine – University of Alberta
  • Overall Official(s)
    • Justin Ezekowitz, MBBCh, Principal Investigator, University of Alberta

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