THERAPY-HYBRID-BPA Trial
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- STATUS
- Recruiting
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- End date
- Jan 28, 2025
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- participants needed
- 72
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- sponsor
- National Hospital Organization Okayama Medical Center
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, Effects of Chemotherapy, Anemic Cancer, Habit Reversal, Surviving Abuse, Abdominal Surgery, Primary Insulin Hypersecretion, Open Heart Surgery, Cancer Prevention, Stasis Dermatitis, Nerve Injury, Pseudobulbar Affect, Joint Injuries, Chronic Pelvic Pain, Pelvic Adhesions, Mental Disability, Dental Filling, Low Testosterone, Myopic Macular Degeneration, Spinocerebellar Disorders, Complicated Grief, Serial Evaluation of Ductal Epithelium, Renal Anemia, Chronic Renal Anemia, Recurrent Pregnancy Loss, Testotoxikose, Functional Dyspepsia, Pulmonary Arterial Hypertension, Infantile Fibrosarcoma, Severe Premenstrual Symptom, Partial Medial Meniscectomy, Memory Problems, Gambling Problems, Cancer Treatment, Indikation: Diabetes - Typ II, Spine Athroplasty, Catheter Complications, Late Infantile Neuronal Ceroid Lipfuscinsosis, 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 |
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| Treatment | Riociguat Oral Tablet |
| Clinical Study Identifier | NCT04600492 |
| Sponsor | National Hospital Organization Okayama Medical Center |
| Last Modified on | 26 January 2021 |
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