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THERAPY-HYBRID-BPA Trial

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ClinicalTrials.gov Identifier: NCT04600492
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
National Hospital Organization Okayama Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Riociguat Oral Tablet Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, placebo-controlled study
Masking: Double (Participant, Investigator)
Masking Description: A double-blind, placebo-controlled study
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : October 16, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : January 28, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Peak CI change [ Time Frame: from baseline to 16 weeks ]
    Change in Peak CI during the cardiopulmonary exercise test (CPET)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600492


Contacts
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Contact: Hiroto Shimokawahara, MD,PhD +81-86-294-9911 hiroto.shimokk@gmail.com
Contact: Yutaka Ito +81-52-951-1111 ext 2493 study.office@nnh.go.jp

Locations
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Japan
National Hospital Org anization Okayama Medical Center Recruiting
Okayama, Japan, 701-1192
Contact: Hiroto Shimokawahara, MD,PhD    +81-86-294-9911    hiroto.shimokk@gmail.com   
Contact: Miki Yanagihara    +81-86-294-9911    okmc-iec@nifty.com   
Sponsors and Collaborators
National Hospital Organization Okayama Medical Center
Bayer Yakuhin, Ltd.
Investigators
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Study Director: Yutaka Ito National Hospital Organization Nagoya Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Hospital Organization Okayama Medical Center
ClinicalTrials.gov Identifier: NCT04600492    
Other Study ID Numbers: Riociguat-CTEPH
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Hospital Organization Okayama Medical Center:
Chronic Thromboembolic Pulmonary Hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action