Unique ID issued by UMIN | UMIN000029928 |
---|---|
Receipt number | R000034151 |
Scientific Title | Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH |
Date of disclosure of the study information | 2017/11/10 |
Last modified on | 2018/03/30 01:04:46 |
Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH
Early intervention for exercise-induced or cold-pressor-induced PH
Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH
Early intervention for exercise-induced or cold-pressor-induced PH
Japan |
exercise-induced pulmonary hypertension, cold-pressor-induced pulmonary hypertension
Cardiology | Adult |
Others
NO
1) To elucidate the clinical coarse of exercise-induced pulmonary hypertension (mean pulmonary arterial pressure >30 mmHg during exercise)associated with connective tissue disease
2) To evaluate the efficacy of early pharmacological intervention for exercise-induced pulmonary hypertension associated with connective tissue disease
3) To elucidate the clinical coarse of cold-pressor-induced pulmonary hypertension associated with connective tissue disease
Efficacy
the change from baseline to year 3 in mean pulmonary arterial pressure at rest
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Pharmacological intervention group.
Pulmonary arterial hypertension specific drug
(PDE 5 inhibitor and/or endothelin receptor antagonist) shall be orally administered.
Non pharmacological intervention group.
20 | years-old | <= |
Not applicable |
Male and Female
Male and female adult patients with connective tissue disease who have been diagnosed with Exercise induced pulmonary hypertension.
Confirmed diagnosis of exercise induced pulmonary hypertension with:
- mPAP < 25 mmHg at rest
- mPAP >= 30 mmHg during exercise
-Received pulmonary arterial hypertension specific therapy
-History of ischemic heart disease
-Severe renal impairment (creatinine clearance <30 ml/min) at Screening
-Severe hepatic impairment (Child-Pugh class C with or without cirrhosis) at Screening
-Uncontrolled hypertension (>=180/110 mmHg) at Screening
-Severe hypotension (<90/50 mmHg) at Screening
-active cancer
-Females who are pregnant or breastfeeding
-Noncompliance with previous medical regimens
-Participated in a clinical study involving another investigational drug
50
1st name | |
Middle name | |
Last name | Yoshito Ogihara |
Mie University Graduate School of Medicine
Department of Cardiology and Nephrology
2-174, Edobashi, Tsu, Mie
059-231-5015
yoshito@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshito Ogihara |
Mie University Graduate School of Medicine
Department of Cardiology and Nephrology
2-174, Edobashi, Tsu, Mie
059-231-5015
yoshito@clin.medic.mie-u.ac.jp
Mie University Graduate School of Medicine
Department of Cardiology and Nephrology
Japan Science and Technology Agency
Japanese Governmental office
NO
三重大学医学部附属病院(三重県)
2017 | Year | 11 | Month | 10 | Day |
Unpublished
Terminated
2009 | Year | 07 | Month | 03 | Day |
2009 | Year | 07 | Month | 03 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 30 | Day |
2017 | Year | 11 | Month | 10 | Day |
2018 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034151