New Orleans Pulmonary Hypertension Biobank

NCT03269630 | Recruiting

• 1 other identifier: LSU
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Collection of biospecimens

  Biospecimen collection only

  10 years

Study Arms (3)

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

Outpatient right heart catheterization patients

-Outpatients undergoing right heart catheterization for any indication

Other: No intervention. Biospecimen collection only

Healthy controls

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

Other: No intervention. Biospecimen collection only

Interventions

No intervention. Biospecimen collection only OTHER

Biospecimen collection

Clinic patients (Comprehensive Pulmonary Hypertension Center); Healthy controls; Outpatient right heart catheterization patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

University Medical Center-New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum, plasma, buffy coat, PBMCs) Urine Stool

MeSH Terms

Conditions

Hypertension, Pulmonary; Scleroderma, Systemic; Mixed Connective Tissue Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Matthew R Lammi, MD, MSCR

CONTACT

5045684634; mlammi@lsuhsc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: December 29, 2017
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)