Heart Failure
Conditions
Keywords
Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome
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.
Interventions
DIETARY_SUPPLEMENTAcacia Gum
dietary supplement will be added to the participant's usual diet
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP | 12 weeks | change in NT-proBNP level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Composite Clinical Outcomes | 12 weeks | All cause death, hospitalizations and emergency department visits |
| 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 |
| 6-Minute Walk Test | 12 weeks | Change in 6-Minute Walk test |
Countries
Canada
Outcome results
None listed