Pulmonary HypertensionPHBRNCT04808596
Pulmonary Hypertension Biorepository and Registry
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension Due to Left Heart Disease
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 31 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Pulmonary Hypertension Group 1-5
Who may be able to join
- 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
Who cannot join
- Participant declines to participate (living patients only)
- Participant is unable to provide informed consent (living patients only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberly Cygan, MBA, BSN, RN contact
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Luigi R Boccardi, Ed.D., MPH, 9135884022, lboccardi@kumc.edu
Kimberly Cygan, MBA, BSN, RN, kcygan@kumc.edu
About this study
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.
Read the 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
- 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
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension, Hypoxia, Lipodystrophy, Congenital Generalized, Type 3
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Clinical Data
Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research.
Measured: From Enrollment to 6 Months
Establish a Biorepository
Establish a collection of biospecimens from patients with pulmonary hypertension.
Measured: From Enrollment to 6 Months
Biospecimens Collection
Correlate biospecimens to longitudinally collected individual patient data.
Measured: From Enrollment to 12 Months
Collaborate
Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies.
Measured: From Enrollment to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 Aug 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Spikes, MD, University of Kansas Medical Center
- Investigators
- Leslie A Spikes, MD, Principal investigator, Assistant Professor of MedicineLuigi R Boccardi, Ed.D., MPH, Study director, Director of Pulmonary Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808596
- Sponsor's protocol ID
- STUDY#00145817
- Acronym
- PHBR
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact Luigi Boccardi to discuss accessing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension Biorepository and Registry
- ClinicalTrials.gov ID
- NCT04808596
- Acronym / sponsor ID
- PHBR / STUDY#00145817
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Hypertension Group 1-5
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participant declines to participate (living patients only)
- Participant is unable to provide informed consent (living patients only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect Clinical Data
Time frame: From Enrollment to 6 Months
Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research.
Establish a Biorepository
Time frame: From Enrollment to 6 Months
Establish a collection of biospecimens from patients with pulmonary hypertension.
Biospecimens Collection
Time frame: From Enrollment to 12 Months
Correlate biospecimens to longitudinally collected individual patient data.
Collaborate
Time frame: From Enrollment to 24 Months
Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. Contact Luigi Boccardi to discuss accessing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Cygan, MBA, BSN, RN contact
Leslie A Spikes, MD principal investigator
Assistant Professor of Medicine
Luigi R Boccardi, Ed.D., MPH study director
Director of Pulmonary Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi R Boccardi, Ed.D., MPH (9135884022, lboccardi@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Clinical Data (time frame: From Enrollment to 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.