THERAPY-HYBRID-BPA Trial

  • STATUS
    Recruiting
  • End date
    Jan 28, 2025
  • participants needed
    72
  • sponsor
    National Hospital Organization Okayama Medical Center
Updated on 26 January 2021
right heart catheterization
riociguat

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.

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.

Details
Condition Pulmonary Hypertension, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Memory Problems
Treatment Riociguat Oral Tablet
Clinical Study IdentifierNCT04600492
SponsorNational Hospital Organization Okayama Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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