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

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT03409926
• Collaborator: (none)
• Enrollment: 51
• Locations: 3
• Arms: 3
• Actual Duration (Months): 39.9
• Patients Per Site: 17
• Patients Per Site Per Month: 0.4

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 Disease	Intervention/Treatment	Phase
Heart Failure	Dietary Supplement: Acacia Gum	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 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
• Actual Primary Completion Date: Jan 10, 2022
• Actual Study Completion Date: Jan 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. NT-proBNP [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

6. ST-2 [12 weeks]

   change in ST-2 level

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

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
2	Royal Alexandra Hospital	Edmonton	Alberta	Canada	T5H 3V9
3	Mazankowski Heart Institute	Edmonton	Alberta	Canada	T6G 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: Aug 18, 2022
• Last Verified: Aug 1, 2022

• 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: Heart Disease; Cardiovascular Disease; Diet; Fiber; Microbiome
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Aug 18, 2022