NCT02188381|Completed
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Sponsor study identifier
Secondary identifiers
observational
292
1 country
1
Study Start
July 2014
Actual (reported)Primary Completion
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Actual (reported)July 9, 2014
Actual (reported)July 11, 2014
Actual (reported)August 2020
Actual (reported)August 2020
Actual (reported)Characterize gut microbiota composition at phylum level
Stool samples to analyze the composition of the microbiota, extracted bacterial genomic DNA will be used as a template for PCR reactions targeting the V4-V5 variable regions of the 16S rRNA gene. Amplicons generated from the PCR will be run on the Illumina MiSeq sequencing platform available in our laboratory to profile microbial communities at phylum level.
24 hours
Characterize gut microbiota composition at genus level
Stool samples to analyze the composition of the microbiota, extracted bacterial genomic DNA will be used as a template for PCR reactions targeting the V4-V5 variable regions of the 16S rRNA gene. Amplicons generated from the PCR will be run on the Illumina MiSeq sequencing platform available in our laboratory to profile microbial communities at genus level.
24 hours
Reduction in BP is associated with changes in gut microbiota composition in RH subjects.
Baseline, 3 months
IS hypertension associated with increased sympathetic activity and decreased parasympathetic activity and whether minocycline or other tetracyclines are effective to improve this balance
Baseline and 3 months
To determine if characterization of gut microbiota in at risk patients predicts long term care utilization and/or cardiovascular outcomes
Up to 5 years
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.
Subjects with controlled hypertension will provide a one time stool sample and a blood sample.
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.
These subject will be asked to provide two stool samples and two blood samples. One at baseline and one after 3 months of therapy.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will initially enroll 10 patients without hypertension as normal controls, and 10 patients with controlled hypertension and 10 patients with resistant hypertension to characterize gut microbiota. In addition, all patients enrolled in IRB# 102-2013 will be approached for possible participation.
Cardiovascular Clinic at UF Health
Gainesville, Florida, 32610, United States
Stool Samples
Carl Pepline, MD
University of Florida
292 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2014
First Posted
July 11, 2014
Study Start
July 2014
Actual (reported)Primary Completion
Management of Uncontrolled Hypertension (HTN)
Subjects with controlled hypertension will provide a one time stool sample and a blood sample.
Contact the study team to confirm eligibility.
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)Last Updated
August 17, 2025
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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