The Need for FibEr Addition in SympTomatic Heart Failure

Heart Failure Clinical Trial

— FEAST-HF  

Official title:

The Need for FibEr Addition in SympTomatic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409926
• Other study ID #: Pro00078692
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: January 10, 2022

Study information

• Verified date: August 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Mazankowski Heart Institute	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP	change in NT-proBNP level	12 weeks
Secondary	Composite Clinical Outcomes	All cause death, hospitalizations and emergency department visits	12 weeks
Secondary	Quality of Life	Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire	12 weeks
Secondary	NYHA Functional Class	Change in NYHA class treated as a categorical variable	12 weeks
Secondary	6-Minute Walk Test	Change in 6-Minute Walk test	12 weeks
Secondary	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
Secondary	ST-2	change in ST-2 level	12 weeks