UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH
Title of the study (Brief title)	Early intervention for exercise-induced or cold-pressor-induced PH
Region	Japan

Condition
Condition	exercise-induced pulmonary hypertension, cold-pressor-induced pulmonary hypertension
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change from baseline to year 3 in mean pulmonary arterial pressure at rest
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pharmacological intervention group. Pulmonary arterial hypertension specific drug (PDE 5 inhibitor and/or endothelin receptor antagonist) shall be orally administered.
Interventions/Control_2	Non pharmacological intervention group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	-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
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshito Ogihara
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5015
Email	yoshito@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Yoshito Ogihara
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5015
Homepage URL
Email	yoshito@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine Department of Cardiology and Nephrology
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	三重大学医学部附属病院(三重県)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 07 Month 03 Day
Anticipated trial start date	2009 Year 07 Month 03 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 30 Day
Date trial data considered complete	2018 Year 03 Month 30 Day
Date analysis concluded	2018 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034151