The Need for FibEr Addition in SympTomatic Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Acacia Gum

• Registration Number: NCT03409926
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Study Start: 2018-09-13
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acacia Gum 10 grams/day	Acacia Gum	fermentable dietary fiber
Microcrystalline Cellulose (MCC) 10 grams/day	Acacia Gum	non-fermentable active control
Acacia Gum 5 grams/day	Acacia Gum	fermentable dietary fiber

Primary Outcome Measures

Name	Time	Method
NT-proBNP	12 weeks	change in NT-proBNP level

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Mazankowski Heart Institute; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada