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Trial record 1 of 1 for:    FEAST-HF
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The Need for FibEr Addition in SympTomatic Heart Failure (FEAST-HF)

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ClinicalTrials.gov Identifier: NCT03409926
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Justin Ezekowitz, University of Alberta

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 disease Intervention/treatment Phase
Heart Failure Dietary Supplement: Acacia Gum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 13, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Acacia

Arm Intervention/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




Primary Outcome Measures :
  1. NT-proBNP [ Time Frame: 12 weeks ]
    change in NT-proBNP level

  2. ST2 [ Time Frame: 12 weeks ]
    change in NT-proBNP level


Secondary Outcome Measures :
  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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409926


Contacts
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Contact: Justin Ezekowitz, MBBCh 780-407-8719 feasthf@ualberta.ca
Contact: Karin Kushniruk, RN, PhD feasthf@ualberta.ca

Locations
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Canada, Alberta
Mazankowski Heart Institute Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Justin Ezekowitz, MD         
Principal Investigator: Justin Ezekowitz, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Justin Ezekowitz, MBBCh University of Alberta

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Responsible Party: Justin Ezekowitz, Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT03409926     History of Changes
Other Study ID Numbers: Pro00078692
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Justin Ezekowitz, University of Alberta:
Heart Disease
Cardiovascular Disease
Diet
Fiber
Microbiome

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases