Recruiting

Observational Study

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT03269630

Conditions

Pulmonary Hypertension

Systemic Sclerosis

Mixed Connective Tissue Disease

Heart Failure With Normal Ejection Fraction

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

No intervention. Biospecimen collection only

Study Details

Brief summary:

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.

Conditions

Pulmonary Hypertension

Systemic Sclerosis

Mixed Connective Tissue Disease

Heart Failure With Normal Ejection Fraction

Healthy

Study ID

NCT03269630

Start date

Dec 29, 2017

Status verified date

Sep, 2021

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

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

No intervention. Biospecimen collection only

Biospecimen collection

Primary outcome measure

  • Collection of biospecimens [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Matthew R Lammi, MD, MSCR

5045684634mlammi@lsuhsc.edu

Locations

University Medical Center-New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Matthew Lammi, MD, MSCR

504-568-4634mlammi@lsuhsc.edu

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Sep 10, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2021-09-10.