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

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ClinicalTrials.gov Identifier: NCT04104490
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
University of Florida

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
Pulmonary Arterial Hypertension

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.


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Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
Actual Study Start Date : June 6, 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Group/Cohort
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.



Primary Outcome Measures :
  1. Gut-microbial dysbiosis [ Time Frame: 3 weeks ]
    Identification of fecal microbiota and the function of the gut microbial community


Biospecimen Retention:   Samples Without DNA
fecal sample containing microbial DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from pulmonary circulation clinic (Brazil) and the Mayo Clinic (Cardiovascular Division) in Jacksonville, FL
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104490


Contacts
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Contact: Elaine Sumners, PhD (352) 294-0440 esumners@ufl.edu

Locations
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United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Brian P Shapiro, MD    904-953-7361    shapiro.brain@mayo.edu   
Brazil
Universidade Federal de Ciências da Saúde de Porto Alegre Completed
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
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Principal Investigator: Mohan Raizada University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04104490     History of Changes
Other Study ID Numbers: IRB201900896 - N
R01HL102033 ( U.S. NIH Grant/Contract )
IRB# 16-001964 ( Other Identifier: Mayo Clinic )
CAAE: 44197015.0.0000.5327 ( Other Identifier: Federal University of Health Sciences Porto Alegre, Brazil )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data for primary and secondary outcomes will be made available to other researchers
Supporting Materials: Study Protocol
Time Frame: Data will be released a year after completion of the study and or publication of manuscripts containing the data as required by the journal and NIH guidelines.
Access Criteria: The sequence data will be deposited on publicly available sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Dysbiosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes