The Need for FibEr Addition in SympTomatic Heart Failure

NCT03409926 — Not applicable, Completed, 51 participants, University of Alberta

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Registry	NCT03409926, acronym FEAST-HF
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	51 (Actual)
Sponsor	University of Alberta (Other)
Conditions	Heart Failure
Interventions	Acacia Gum (Dietary supplement)
Dates	start 2018-09-13, primary completion 2022-01-10, completion 2022-01-10, first posted 2018-01-24, last updated 2022-08-18
Locations	3 sites in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Microcrystalline Cellulose (MCC) 10 grams/day	Active comparator	Dietary Supplement: Acacia Gum	non-fermentable active control
Acacia Gum 5 grams/day	Experimental	Dietary Supplement: Acacia Gum	fermentable dietary fiber
Acacia Gum 10 grams/day	Experimental	Dietary Supplement: Acacia Gum	fermentable dietary fiber

Acacia Gum (Dietary supplement): dietary supplement will be added to the participant's usual diet

+Outcome measures

Primary outcomes

NT-proBNP [12 weeks]: change in NT-proBNP level

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (3)

Facility	City	Country
University of Calgary	Calgary, Alberta	Canada
Royal Alexandra Hospital	Edmonton, Alberta	Canada
Mazankowski Heart Institute	Edmonton, Alberta	Canada

+Publications

Results publication: Colin-Ramirez E, Alemayehu W, McAlister FA, Howlett JG, Willing BP, Forgie A, Madsen K, Dyck JRB, Ezekowitz JA. The Need for Fiber Addition in Symptomatic Heart Failure (FEAST-HF): A Randomized Controlled Pilot Trial. CJC Open. 2023 Jul 18;5(10):760-769. doi: 10.1016/j.cjco.2023.07.005. eCollection 2023 Oct. PMID 37876886

+Investigators

Justin Ezekowitz, MBBCh, Principal investigator, University of Alberta

My Notes

Public

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