Pulmonary Hypertension Biorepository and Registry (PHBR)

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Hypertension Due to Left Heart Disease; Pulmonary Hypertension, Primary, 4; Pulmonary Hypertension, Primary, 2; Pulmonary Hypertension, Primary, 3; Pulmonary Hypertension, Primary; Pulmonary Hypertension Due to Lung Diseases and Hypoxia

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Luigi R Boccardi, Ed.D., MPH; Phone Number: 9135884022; Email: lboccardi@kumc.edu
• Study Contact Backup: Name: Kimberly Cygan, MBA, BSN, RN; Email: kcygan@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Leslie A Spikes, MD
      • Sub-Investigator: Lewis G Satterwhite, MD
      • Sub-Investigator: Timothy L Williamson, MD, FCCP
      • Contact: Luigi R Boccardi, Ed.D., MPH; Phone Number: 9135884022; Email: lboccardi@kumc.edu
      • Contact: Kimberly Cygan, MBA, BSN, RN; Email: kcygan@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pulmonary Hypertension Group 1-5

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Leslie A Spikes, MD, Assistant Professor of Medicine; Study Director: Luigi R Boccardi, Ed.D., MPH, Director of Pulmonary Research

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Pulmonary Arterial Hypertension; Lung Diseases; Hypertension; Heart Diseases; Hypoxia; Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: STUDY#00145817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Contact Luigi Boccardi to discuss accessing IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No