Status:
COMPLETED
The Role of Gut Microbiota in Hypertension
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Brief Summary
Hypertension is the single most prevalent risk factor for heart diseases, heart failure, kidney failure and stroke. About 1 in 3 adults in the United States have hypertension. Approximately 28-30% of ...
Detailed Description
This is a prospective cohort design. This study will enroll 388 subjects: 81 patients without HTN as a reference group, 81 patients with controlled HTN, 55 patients with uncontrolled HTN, 55 with remo...
Eligibility Criteria
Inclusion
- age \>18 and \<80
- is competent and willing to provide consent
- Inclusion criteria for each subject group:
- Control subjects will have a systolic BP \<140mmHg with no cardiovascular disease
- Patients with controlled hypertension
- Patients with uncontrolled hypertension
- Resistant hypertension subjects will have systolic blood pressure (BP) ≥140 mmHg despite ≥3 anti-hypertensive medications of different classes one of which should be a diuretic
- Patients who are no longer RH subjects and have normal blood pressure
- Subjects participating in NCT 02133872 will be eligible to participate
Exclusion
- currently pregnant or have been pregnant in the last 6 months;
- antibiotic treatment within 2 months of study enrollment;
- currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
- unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
- history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT02188381
Start Date
July 1 2014
End Date
August 1 2020
Last Update
August 17 2025
Active Locations (1)
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1
Cardiovascular Clinic at UF Health
Gainesville, Florida, United States, 32610