The Need for FibEr Addition in SympTomatic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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The Need for FibEr Addition in SympTomatic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Acacia Gum


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microcrystalline Cellulose (MCC) 10 grams/day<br>non-fermentable active control | Dietary Supplement: Acacia Gum<br>* dietary supplement will be added to the participant's usual diet<br>|
| Experimental: Acacia Gum 5 grams/day<br>fermentable dietary fiber | Dietary Supplement: Acacia Gum<br>* dietary supplement will be added to the participant's usual diet<br>|
| Experimental: Acacia Gum 10 grams/day<br>fermentable dietary fiber | Dietary Supplement: Acacia Gum<br>* dietary supplement will be added to the participant's usual diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | change in NT-proBNP level | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinical Outcomes | All cause death, hospitalizations and emergency department visits | 12 weeks | 
| Quality of Life | Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire | 12 weeks | 
| NYHA Functional Class | Change in NYHA class treated as a categorical variable | 12 weeks | 
| 6-Minute Walk Test | Change in 6-Minute Walk test | 12 weeks | 
| Fecal Microbiome Characterization | To examine the gut microbiome in a descriptive manner and characterize predominant species and those linked to Short Chain Fatty Acid production | Baseline, Week 6, Week 12 | 
| ST-2 | change in ST-2 level | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome