Pulmonary Hypertension Biorepository and Registry

NCT04808596 | Recruiting

• 1 other identifier: STUDY#00145817
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pulmonary Hypertension Group 1-5

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypoxia; Lipodystrophy, Congenital Generalized, Type 3

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leslie A Spikes, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Luigi R Boccardi, Ed.D., MPH

  Director of Pulmonary Research

  STUDY DIRECTOR

Central Study Contacts

Luigi R Boccardi, Ed.D., MPH

CONTACT

9135884022; lboccardi@kumc.edu

Kimberly Cygan, MBA, BSN, RN

CONTACT

kcygan@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: August 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)