New Orleans Pulmonary Hypertension Biobank (NO-PH Biobank)

September 9, 2021 updated by: Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center-New Orleans
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from 2 venues: 1) Comprehensive Pulmonary Hypertension Center clinic (pulmonary hypertension, systemic sclerosis without PH, mixed connective tissue disease without PH) and 2) Outpatient right heart catheterization lab. Healthy subjects (age>18, not currently smoking, no chronic medical conditions) will also be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: No intervention. Biospecimen collection only
Biospecimen collection
Outpatient right heart catheterization patients
-Outpatients undergoing right heart catheterization for any indication
Other: No intervention. Biospecimen collection only
Biospecimen collection
Healthy controls
  • Age>18
  • Not actively smoking
  • No chronic medical conditions
Other: No intervention. Biospecimen collection only
Biospecimen collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of biospecimens
Time Frame: 10 years
Biospecimen collection only
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2017

Primary Completion (Anticipated)

October 1, 2027

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

A sharing plan will be developed to share biospecimens with interested researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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