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

Completed

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT04104490
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06-06
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2020-06
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• severe, mild-moderate or no pulmonary arterial hypertensive subjects

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut-microbial dysbiosis	3 weeks	Identification of fecal microbiota and the function of the gut microbial community

Trial Locations

Locations (2)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Universidade Federal de Ciências da Saúde de Porto Alegre; 🇧🇷 Porto Alegre, Brazil