Pulmonary Hypertension Biorepository and Registry | NCT04808596

Studies
Pulmonary Hypertension Biorepository and Registry

NCT04808596

Sponsor

University of Kansas Medical Center

Status

Recruiting

Last Update Posted

Aug 1, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Pulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Hypertension Due to Left Heart Disease
Pulmonary Hypertension, Primary
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Pulmonary Hypertension, Primary, 4
Pulmonary Hypertension, Primary, 2
Pulmonary Hypertension, Primary, 3
Chronic Thromboembolic Pulmonary Hypertension

Interventions

Not provided

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

Status Module

Record Verification Date

Jul 2025

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

Aug 10, 2020Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 22, 2021Actual

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

Jul 29, 2025

Last Update Posted Date

Aug 1, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leslie Spikes, MD, Associate Professor, University of Kansas Medical CenterPrincipal Investigator

Lead Sponsor

University of Kansas Medical CenterOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Detailed Description

The aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all WHO groups I-V to be used for future research in these areas. This will be both a retrospective and prospective project. The registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.

Conditions Module

Conditions

Pulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Hypertension Due to Left Heart Disease
Pulmonary Hypertension, Primary
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Pulmonary Hypertension, Primary, 4
Pulmonary Hypertension, Primary, 2
Pulmonary Hypertension, Primary, 3
Chronic Thromboembolic Pulmonary Hypertension

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collect Clinical Data	Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research.	From Enrollment to 6 Months
Establish a Biorepository	Establish a collection of biospecimens from patients with pulmonary hypertension.	From Enrollment to 6 Months
Biospecimens Collection	Correlate biospecimens to longitudinally collected individual patient data.	From Enrollment to 12 Months
Collaborate	Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies.	From Enrollment to 24 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization
Patient is ≥ 18 years of age or older

Exclusion Criteria:

Participant declines to participate (living patients only)
Participant is unable to provide informed consent (living patients only)

Accepts Healthy Volunteers

Not provided

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

Pulmonary Hypertension Group 1-5

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luigi R Boccardi, Ed.D., MPH	Contact	9135884022		lboccardi@kumc.edu
Kimberly Cygan, MBA, BSN, RN	Contact			kcygan@kumc.edu

Overall Officials

Name	Affiliation	Role
Leslie A Spikes, MD	Assistant Professor of Medicine	Principal Investigator
Luigi R Boccardi, Ed.D., MPH	Director of Pulmonary Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center	Recruiting	Kansas City	Kansas	66160	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Contact Luigi Boccardi to discuss accessing IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Description

Future projects might include genetic testing on your samples. Genetic testing studies pieces of DNA called genes. The cells in your body contain deoxyribonucleic acid, or DNA for short. DNA is passed down from your parents. It carries the genes that determine how you look and how your body works and tells a genetic story about you. Differences in genes may help explain why a particular drug is effective and safe in some people, but not in others. Differences in genes also may explain why some people get certain diseases, but others do not. The genetic information may be important in guiding targeted treatments in the future.

ID	Term
D006976	Hypertension, Pulmonary
D000081029	Pulmonary Arterial Hypertension
D065627	Familial Primary Pulmonary Hypertension
D000860	Hypoxia
C567282	Lipodystrophy, Congenital Generalized, Type 3

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms