The Role of Gut Microbiota in Hypertension

NCT ID: NCT02188381

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 292 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-08-31

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 hypertensive patients suffer from resistant hypertension (RH). Inflammation has been implicated in the pathogenesis of the hypertension. Additional data suggests the involvement of gut microbiota in host normal cardiovascular functions and pathophysiology. Accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. Even though these studies did not address effects of antibiotic treatment on the gut microbiota, it is possible that gut microbiota could affect neurologic inflammation. Finally, intestinal microbiota has recently been proposed to modulate blood pressure (BP) through production of short-chain fatty acids. In order to investigate this, the investigators hypothesize that gut microbiota is involved in the neuroinflammation-mediated initiation and establishment of RH, and targeting gut microbiota by minocycline would produce beneficial outcomes in RH.

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 remodeled RH, and 81 patients with RH to characterize gut microbiota composition. Subjects will provide stool samples for analysis. Subjects will also provide a blood sample for inflammatory marker and stem cell analysis.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal controls without hypertension

Control subjects will have a systolic BP \<140mmHg with no cardiovascular disease. These subjects will provide a one time stool sample and a blood sample.

Stool Sample and Blood Sample

Intervention Type: OTHER

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Controlled hypertension

Subjects with controlled hypertension will provide a one time stool sample and a blood sample.

Stool Sample and Blood Sample

Intervention Type: OTHER

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Resistant hypertension

Resistant hypertension subjects will have systolic blood pressure (BP) ≥140 mmHg despite ≥3 anti-hypertensive medications of different classes. These subjects will provide a one time stool sample and a blood sample.

Stool Sample and Blood Sample

Intervention Type: OTHER

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Prior enrolled in NCT 02133872

These subject will be asked to provide two stool samples and two blood samples. One at baseline and one after 3 months of therapy.

Stool Sample and Blood Sample

Intervention Type: OTHER

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Remodeled Resistent Hypertension

Subjects with controlled hypertension will provide a one time stool sample and a blood sample.

Stool Sample and Blood Sample

Intervention Type: OTHER

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Interventions

Stool Sample and Blood Sample

All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age >18 and <80
• is competent and willing to provide consent

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Pepline, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Cardiovascular Clinic at UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

1R01HL132448-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201400233-N

Identifier Type: -

Identifier Source: org_study_id