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Completed

NCT Number: NCT03409926

The Need for FibEr Addition in SympTomatic Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acacia Gum

Dietary Supplement

dietary supplement will be added to the participant's usual diet

Primary outcomes

  1. NT-proBNP

    Time frame: 12 weeks

    change in NT-proBNP level

Secondary outcomes

  1. Composite Clinical Outcomes

    Time frame: 12 weeks

    All cause death, hospitalizations and emergency department visits

  2. Quality of Life

    Time frame: 12 weeks

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

  3. NYHA Functional Class

    Time frame: 12 weeks

    Change in NYHA class treated as a categorical variable

  4. 6-Minute Walk Test

    Time frame: 12 weeks

    Change in 6-Minute Walk test

  5. 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

  6. ST-2

    Time frame: 12 weeks

    change in ST-2 level

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: FEAST-HF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2018
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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