The Role of Gut Microbiota in Hypertension

  • STATUS
    Recruiting
  • End date
    Oct 13, 2023
  • participants needed
    426
  • sponsor
    University of Florida
Updated on 13 February 2021
cardiovascular disease
stroke
systolic blood pressure
renal failure
hypertensive medication
uncontrolled hypertension
resistant hypertension

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.

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.

Details
Condition Vascular Diseases, Vascular Diseases, Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Diabetes and Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment Stool Sample and Blood Sample
Clinical Study IdentifierNCT02188381
SponsorUniversity of Florida
Last Modified on13 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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