New Orleans Pulmonary Hypertension Biobank | NCT03269630

Studies
New Orleans Pulmonary Hypertension Biobank

NCT03269630

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Status

Recruiting

Last Update Posted

Sep 10, 2021Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Pulmonary Hypertension
Systemic Sclerosis
Mixed Connective Tissue Disease
Heart Failure With Normal Ejection Fraction
Healthy

Interventions

No intervention. Biospecimen collection only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2017Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2021

Last Update Posted Date

Sep 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Lammi, Associate Professor of Medicine, Louisiana State University Health Sciences Center in New OrleansPrincipal Investigator

Lead Sponsor

Louisiana State University Health Sciences Center in New OrleansOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention. Biospecimen collection only	Other	Biospecimen collection	Clinic patients (Comprehensive Pulmonary Hypertension Center) Healthy controls

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew R Lammi, MD, MSCR	Contact	5045684634		mlammi@lsuhsc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center-New Orleans	Recruiting	New Orleans	Louisiana	70112	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D012595	Scleroderma, Systemic
D008947	Mixed Connective Tissue Disease

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided