New Orleans Pulmonary Hypertension Biobank

NCT ID: NCT03269630

Last Updated: 2021-09-10

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

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-29

Study Completion Date

2027-10-31

Brief Summary

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Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure \>=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.

Detailed Description

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Conditions

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Pulmonary Hypertension Systemic Sclerosis Mixed Connective Tissue Disease Heart Failure With Normal Ejection Fraction Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic patients (Comprehensive Pulmonary Hypertension Center)

* Pulmonary hypertension patients (WHO group 1-5)
* Systemic sclerosis patients without pulmonary hypertension
* Mixed connective tissue disease patients without pulmonary hypertension

No intervention. Biospecimen collection only

Intervention Type OTHER

Biospecimen collection

Outpatient right heart catheterization patients

-Outpatients undergoing right heart catheterization for any indication

No intervention. Biospecimen collection only

Intervention Type OTHER

Biospecimen collection

Healthy controls

* Age\>18
* Not actively smoking
* No chronic medical conditions

No intervention. Biospecimen collection only

Intervention Type OTHER

Biospecimen collection

Interventions

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No intervention. Biospecimen collection only

Biospecimen collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR
* Undergoing outpatient right heart catheterization

Exclusion Criteria

* Age\<18
* Pregnant
* Unable to understand English
* Currently incarcerated
* Unwilling or unable to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Matthew Lammi

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center-New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew R Lammi, MD, MSCR

Role: CONTACT

5045684634

Facility Contacts

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Matthew Lammi, MD, MSCR

Role: primary

504-568-4634

Other Identifiers

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LSU

Identifier Type: -

Identifier Source: org_study_id

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