NCT05719415

Brief Summary

Chronic thromboembolic pulmonary hypertension \[CTEPH\] is caused by pulmonary emboli that have enlarged in pulmonary arteries and have become organized into the vessel wall. Many patients with CTEPH are treated with balloon pulmonary angioplasty \[BPA\] which mechanically opens the narrow pulmonary arteries. It is unclear how much downstream functional pulmonary capillary surface area \[FCSA\] is recovered during BPA. The investigators plan to measure FCSAIn CTEPH patients, before and after a session of BPA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2023Jan 2028

First Submitted

Initial submission to the registry

January 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

January 30, 2023

Last Update Submit

September 22, 2025

Conditions

Hypertension, PulmonaryPulmonary Thromboembolisms

Outcome Measures

Primary Outcomes (1)

  • Change in pulmonary functional capillary surface area

    Measurement of transpulmonary metabolism of benzoyl-Phe-Ala-Pro

    4 hours

Study Arms (1)

Pre and post BPA

EXPERIMENTAL
Other: Measurement of pulmonary functional capillary surface area

Interventions

Measurement of pulmonary functional capillary surface areaOTHER

Measurement of transpulmonary metabolism of trace injected doses of benzoyl-Phe-Ala-Pro

Pre and post BPA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients eligible for balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension

You may not qualify if:

  • Treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers,
  • Presence of patent foramen ovale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Langleben

Montreal, Quebec, H3W 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesEmbolismEmbolism and Thrombosis

Central Study Contacts

David Langleben, MD

CONTACT

5143407531david.langleben@mcgill.ca

Lyda Lesenko, MD

CONTACT

514-340-8222llesenko@jgh.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 9, 2023

Study Start

March 23, 2023

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)