New Orleans Pulmonary Hypertension Biobank

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03269630
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Louisiana State University Health Sciences Center in New Orleans
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension, Systemic Sclerosis, Mixed Connective Tissue Disease, Heart Failure With Normal Ejection Fraction, Healthy
Arms & Interventions

Arms

: 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

: Outpatient right heart catheterization patients

-Outpatients undergoing right heart catheterization for any indication

: Healthy controls

Age>18 Not actively smoking No chronic medical conditions

Interventions

Other: - No intervention. Biospecimen collection only

Biospecimen collection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University Medical Center-New Orleans, New Orleans, Louisiana

Status

Recruiting

Address

University Medical Center-New Orleans

New Orleans, Louisiana, 70112

Site Contact

Matthew Lammi, MD, MSCR

[email protected]

504-568-4634