NCT04052243

Brief Summary

Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure. Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow. The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 11, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 11, 2019

Last Update Submit

July 18, 2022

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Slope of mPA/CO after BPA

    Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months

    6 months after last BPA session

Secondary Outcomes (3)

  • Change in resting PVR after BPA

    6 months after last BPA session

  • Change in 6 MWT after BPA

    6 months after last BPA session

  • Change in NT-proBNP after BPA

    6 months after last BPA session

Study Arms (1)

All patients

OTHER

Exercise is added to resting right heart catheterization

Diagnostic Test: Invasive exercise testing

Interventions

Invasive exercise testingDIAGNOSTIC_TEST

Invasive hemodynamic exercise testing

All patients

Eligibility Criteria

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

You may qualify if:

  • Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.

You may not qualify if:

  • Patients unable to perform ergometer exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of cardiology, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Nagoya University Hospital

Nagoya, Japan

NOT YET RECRUITING

European Health Center

Otwock, Poland

RECRUITING

Central Study Contacts

Mads J Andersen, MD, PhD

CONTACT

+45784500000madsae@rm.dk

Jens Erik Nielsen-Kudsk, MD, Dm.Sci.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Exercise is added to the resting right heart catheterization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2019

First Posted

August 9, 2019

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)PL(1)DK(1)