New Orleans Pulmonary Hypertension Biobank

Recruiting

• Conditions: Systemic Sclerosis; Pulmonary Hypertension; Healthy; Heart Failure With Normal Ejection Fraction; Mixed Connective Tissue Disease
• Interventions: Other: No intervention. Biospecimen collection only

• Registration Number: NCT03269630
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2017-12-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-10
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatient right heart catheterization patients	No intervention. Biospecimen collection only	-Outpatients undergoing right heart catheterization for any indication
Clinic patients (Comprehensive Pulmonary Hypertension Center)	No intervention. Biospecimen collection only	* Pulmonary hypertension patients (WHO group 1-5) * Systemic sclerosis patients without pulmonary hypertension * Mixed connective tissue disease patients without pulmonary hypertension
Healthy controls	No intervention. Biospecimen collection only	* Age\>18 * Not actively smoking * No chronic medical conditions

Primary Outcome Measures

Name	Time	Method
Collection of biospecimens	10 years	Biospecimen collection only

Trial Locations

Locations (1)

University Medical Center-New Orleans; 🇺🇸 New Orleans, Louisiana, United States