THERAPY-HYBRID-BPA Trial

October 22, 2020 updated by: National Hospital Organization Okayama Medical Center

The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty

Riociguat could improve the exercise capacity and residual symptoms in patients with chronic thromboembolic pulmonary hypertension (CTEPH) even after normalization of pulmonary arterial pressure by balloon pulmonary angioplasty (BPA). This randomized controlled trial study aimed to clarify whether the improvement of peak cardiac index (CI) during exercise maintains or not between the riociguat continued group and the riociguat discontinued group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CTEPH is a disease that causes progressive pulmonary hypertension due to stenoses or occlusions in the pulmonary artery due to an organized thrombus. And this is a disease that results in right heart failure and death unless early diagnosis and appropriate treatment are performed. Pulmonary endarterectomy (PEA), which surgically removes the intimal thrombus, has been established as the treatment of choice for CTEPH. In the AHA/ACC guideline and ESC guideline, PEA for CTEPH is class IC (1). In 2014, a soluble guanylate cyclase stimulant (generic name: riociguat), which is one of the therapeutic agents for pulmonary hypertension, was approved for patients with CTEPH who are ineligible for PEA, and residual pulmonary hypertension after PEA (2). In addition, it has been reported that BPA, which is a catheter interventional treatment, is also effective to improve hemodynamics in inoperable patients with CTEPH (3, 4). However, some patients have residual symptoms such as dyspnea on exertion even after normalization in hemodynamics by BPA. A randomized control study should be done to confirm the necessary of continuation of riociguat for such patients.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Org anization Okayama Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who meet CTEPH diagnostic criteria (complying with 2017 Japanese Cardiovascular Society Guidelines diagnostic criteria)
  2. Patients with diagnosed as a contraindication of pulmonary endarterectomy by an experienced surgeon in the central diagnosis
  3. Patients who were adjusted to reach the appropriate dose of riociguat within 8 weeks and were able to continue riociguat thereafter
  4. Patients who underwent BPA once or more after the dose adjustment of riociguat
  5. Patients who have been able to continue taking the same dose of riociguat for more than 3 months
  6. Patients who can obtain written informed consent from the patients and legal representatives
  7. Patients with WHO functional class II or III at the time of the allocation
  8. Over the age of 18 and under 85 at the time of obtaining informed consent
  9. Patients with the resting CI value of less than 3.0 L/min/m2 in the right heart catheterization test immediately before the allocation
  10. Patients with the mean pulmonary artery pressure less than 25 mmHg in a right heart catheterization test immediately before the allocation

Exclusion Criteria:

  1. Patients who are eligible for pulmonary endarterectomy (PEA)
  2. Patients with pulmonary hypertension other than class 4 by NICE classification
  3. Patients having difficulty in performing cardiopulmonary exercise test (CPET)
  4. Patients with severe right heart failure requiring cardiotonic drugs
  5. Patients with severe heart disease
  6. Patients with severe liver damage
  7. Patients with systolic blood pressure less than 90 mmHg at the screening
  8. Patients with shunt disease
  9. Patients with severe renal dysfunction (CCr < 15 mL/min) requiring hemodialysis
  10. Patients with life expectancy less than 2 years
  11. Being pregnant or lactating
  12. Patients who are contraindicated for riociguat
  13. Patients using other unlicensed drugs
  14. Patients who used pulmonary vasodilators within 4 weeks after obtaining the informed consent of the right heart catheterization test.
  15. Patients whom the investigator determines that the participation in this study is inappropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: Active drug group Riociguat
Riociguat 0.5mg、1.0mg、2.5mg
Drug: Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
Placebo Comparator: Placebo group
Placebo 0.5mg、1.0mg、2.5mg
Drug: Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak CI change
Time Frame: from baseline to 16 weeks
Change in Peak CI during the cardiopulmonary exercise test (CPET)
from baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hospital Organization Okayama Medical Center

Collaborators

Bayer Yakuhin, Ltd.

Investigators

  • Study Director: Yutaka Ito, National Hospital Organization Nagoya Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 16, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

January 28, 2025

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Riociguat-CTEPH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension, Pulmonary

Clinical Trials on Riociguat Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe