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NCT04104490 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04104490
Other study ID # IRB201900896 - N
Secondary ID R01HL102033IRB#
Status Completed
Phase
First received
Last updated
Start date June 6, 2015
Est. completion date December 31, 2021

Study information
Verified date October 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date December 31, 2021
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Universidade Federal de Ciências da Saúde de Porto Alegre Porto Alegre
United States Mayo Clinic Jacksonville Jacksonville Florida

Sponsors (4)
Lead Sponsor Collaborator
University of Florida Federal University of Health Science of Porto Alegre, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gut-microbial dysbiosis Identification of fecal microbiota and the function of the gut microbial community 3 weeks
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