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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcrystalline Cellulose (MCC) 10 grams/day | Active Comparator | non-fermentable active control |
|
| Acacia Gum 5 grams/day | Experimental | fermentable dietary fiber |
|
| Acacia Gum 10 grams/day | Experimental | fermentable dietary fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acacia Gum | Dietary Supplement | dietary supplement will be added to the participant's usual diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP | change in NT-proBNP level | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Ezekowitz, MBBCh | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Royal Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37876886 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| 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 |
| Edmonton |
| Alberta |
| T5H 3V9 |
| Canada |
| Mazankowski Heart Institute | Edmonton | Alberta | T6G 2B7 | Canada |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |