An observational study in Pulmonary Arterial Hypertension, sponsored by University of Florida. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by University of Florida · Observational
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.
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.
773 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 79 is below the median of 100 across 201 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Subjects will be recruited from pulmonary circulation clinic (Brazil) and the Mayo Clinic (Cardiovascular Division) in Jacksonville, FL
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Exclusion Criteria:
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.
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 will be healthy people, age- and sex-matched to the other two cohorts, who have no pulmonary artery hypertension.
Gut-microbial dysbiosis
Identification of fecal microbiota and the function of the gut microbial community
Time frame: 3 weeks
Plan to share: Yes — Deidentified data for primary and secondary outcomes will be made available to other researchers
Supporting information: 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.
No publications or documents are linked to this record.
Ran from Jun 2015 to primary completion in Jun 2020, 60 months.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension →