Diet, Vascular Health and the Gut Microbiome in Heart Failure
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-009101
Sponsor Protocol Number: 16-009101
About this study
Heart failure with reduced ejection (HFrEF) is a major health concern. HFrEF is associated with significant endothelial dysfunction (ED). The purpose of this study is to compare the effects of a Western diet (WD) to a high-carbohydrate, high-fiber diet (HCHF) on endothelial function in patients with HFrEF. the study will look at the distribution of intestinal microbe communities after following the diets as well as explore relationships between gut health and ED in patients with HFrEF.
We propose to address this important gap in the literature with a study design that is responsive to needs in the area of healthcare delivery and disease management in this population of patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosed with chronic, compensated congestive heart failure [New York Heart Association (NYHA) Class II-III]
- Between the ages of 40-99 years
Exclusion Criteria:
- Unstable angina
- Recent myocardial infarction (<4 weeks)
- Decompensated heart failure
- NYHA functional class IV
- Complex ventricular arrhythmias at rest
- Symptomatic severe aortic stenosis
- Acute pulmonary embolism
- Acute myocarditis
- Recent hospitalization in the past 6 weeks
- Non-use of ßblockers/angiotensin converting enzyme inhibitors
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Reza Arsanjani, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available