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

NCT04104490 | Completed

• 4 other identifiers: IRB201900896 - NR01HL102033IRB# 16-001964CAAE: 44197015.0.0000.5327
• Study Type: observational
• Target: 79
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Gut-microbial dysbiosis

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

  3 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, CEP 900050-170, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal sample containing microbial DNA

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohan Raizada

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: June 6, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1); BR (1)