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Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension

Sponsor
University of Florida (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04104490
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Mayo Clinic (Other), Federal University of Health Science of Porto Alegre (Other)
79
Enrollment
2
Locations
84.8
Anticipated Duration (Months)
39.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pulmonary arterial hypertension (PAH) is fatal with right heart failure due to raised pulmonary vascular pressure. Gut dysbiosis was identified in animals with pulmonary hypertension. Deidentified human samples will be tested for gut dysbiosis in PAH, circulating bacterial metabolites and markers of inflammation and gut leakiness. The gut microbiome and circulating metabolites, markers of inflammation and gut leakiness of PAH patients and healthy subjects will be compared in deidentified fecal samples and blood.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Stool samples will be collected from people with no, mild-moderate or severe pulmonary arterial hypertension. Bacterial DNA will be extracted from the feces and sequenced by whole genome sequencing (shotgun sequencing). The DNA sequences will be used to identify the bacteria present in the feces, and to model the functions of the gut microbial community in each of the three groups. This will test for gut dysbiosis in pulmonary arterial hypertensive patients compared to healthy subjects. Gut dysbiosis is a condition where the gut bacterial communities are unbalanced and has been implicated in disease processes.

    In subjects recruited in the USA, blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    79 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
    Actual Study Start Date :
    Jun 6, 2015
    Actual Primary Completion Date :
    Jun 1, 2020
    Anticipated Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Severe pulmonary arterial hypertension.

    This cohort will consist of patients with severe pulmonary arterial hypertension. This is defined as mean pulmonary arterial pressure 25 mm Hg or greater and pulmonary artery occlusion pressure 15 mmHg or less measured by right cardiac catheterization and a clinical diagnosis of severe disease. Participants will be without signs of left heart disease, lung disease and or hypoxia, chronic thromboembolic pulmonary hypertension or pulmonary hypertension of unclear multifactorial mechanisms. This is an observational study with no interventions.
    Mild-moderate pulmonary arterial hypertension

    This cohort will consist of patients with mild-moderate pulmonary arterial hypertension. This is defined as mean pulmonary arterial pressure 25 mm Hg or greater and pulmonary artery occlusion pressure 15 mmHg or less measured by right cardiac catheterization and a clinical diagnosis of mild-moderate disease. Participants will be without signs of left heart disease, lung disease and or hypoxia, chronic thromboembolic pulmonary hypertension or pulmonary hypertension of unclear multifactorial mechanisms. This is an observational study with no interventions.
    Reference subjects without pulmonary hypertension

    Reference subjects will be healthy people, age- and sex-matched to the other two cohorts, who have no pulmonary artery hypertension.

    Outcome Measures

    Primary Outcome Measures

    1. Gut-microbial dysbiosis [3 weeks]

      Identification of fecal microbiota and the function of the gut microbial community

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • severe, mild-moderate or no pulmonary arterial hypertensive subjects
    Exclusion Criteria:
    • Patients with pulmonary hypertension due to left heart disease, lung diseases and / or hypoxia, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension with unclear multifactorial mechanisms.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    2 Universidade Federal de Ciências da Saúde de Porto Alegre Porto Alegre Brazil CEP 900050-170

    Sponsors and Collaborators

    • University of Florida
    • National Heart, Lung, and Blood Institute (NHLBI)
    • Mayo Clinic
    • Federal University of Health Science of Porto Alegre

    Investigators

    • Principal Investigator: Mohan Raizada, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04104490
    Other Study ID Numbers:
    • IRB201900896 - N
    • R01HL102033
    • IRB# 16-001964
    • CAAE: 44197015.0.0000.5327
    First Posted:
    Sep 26, 2019
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Pulmonary Arterial Hypertension
    Hypertension
    Dysbiosis

    Study Results

    No Results Posted as of Jan 12, 2022