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Trial record 11 of 30 for:    Pulmonary Hypertension OR Vascular dementia OR Vascular Dementia OR Vascular Contributions to Cognitive Impairment and Dementia | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT04104490
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date September 24, 2019
First Posted Date September 26, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date June 6, 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2019)
Gut-microbial dysbiosis [ Time Frame: 3 weeks ]
Identification of fecal microbiota and the function of the gut microbial community
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
Official Title Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
fecal sample containing microbial DNA
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
Condition Pulmonary Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 24, 2019)
168
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Elaine Sumners, PhD (352) 294-0440 esumners@ufl.edu
Listed Location Countries Brazil,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04104490
Other Study ID Numbers IRB201900896 - N
R01HL102033 ( U.S. NIH Grant/Contract )
IRB# 16-001964 ( Other Identifier: Mayo Clinic )
CAAE: 44197015.0.0000.5327 ( Other Identifier: Federal University of Health Sciences Porto Alegre, Brazil )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Deidentified data for primary and secondary outcomes will be made available to other researchers
Supporting Materials: 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.
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Mayo Clinic
  • Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Mohan Raizada University of Florida
PRS Account University of Florida
Verification Date September 2019