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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-06

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

NCT06409624

Pulmonary Hypertension Chronic Kidney Disease

ACTIVE_NOT_RECRUITING

Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD

NCT03493802

Autosomal Dominant Polycystic Kidney Disease

COMPLETED

Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.

NCT01579032

Arterial Stiffness CHRONIC RENAL FAILURE Left Ventricular Hypertrophy

COMPLETED

Kidney Disease Biomarkers

NCT00255398

Kidney Disease Glomerular Disease Idiopathic Nephrotic Syndrome +2 more

COMPLETED

Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)

NCT00953992

Renal Failure Nutrition Disorders

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes