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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006174
Receipt No. R000007294
Scientific Title Goal-Oriented Therapy Evaluated By Cardiopulmonary Exercise Testing For Pulmonary Arterial Hypertension
Date of disclosure of the study information 2011/08/15
Last modified on 2015/08/16

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Basic information
Public title Goal-Oriented Therapy Evaluated By Cardiopulmonary Exercise Testing For Pulmonary Arterial Hypertension
Acronym GOOD EYE
Scientific Title Goal-Oriented Therapy Evaluated By Cardiopulmonary Exercise Testing For Pulmonary Arterial Hypertension
Scientific Title:Acronym GOOD EYE
Region
Japan

Condition
Condition Pulmonary arterial hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate whether goal-oriented therapy by using cardiopulmonary exercise testing improve prognosis compared to historical group in patient with pulmonary arterial hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Admission due to right heart failure, syncope, arrythmia, and hemoptysis. induction of intravenous epopresterol. Cardiac death.
Key secondary outcomes Exercise tolerance (cardiopulmonary exercise testing, 6-minutes walk distance, WHO functional class, hemodynamics, BNP, QOL score by HADS, SF-8, and PMADL 8. induction of oxygen therapy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
16 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Age lower limited 16 years old, upper limited 85 years old
2) Mean pulmonary arterial pressure at rest was more than eual to 25 mmHg and pulmonary capillary wedge pressure less than equal to 15 mmHg by Swan-Ganz catheterization
3) No abnormal ventilation/perfusion scan
Key exclusion criteria 1) Pulmonary hypertension due to left heart disease, Pulmonary hypertension due to lung diseases and/or hypoxia,
Chronic thromboembolic pulmonary hypertension
2) Pregnant
3) Moderate or severe hepatic failure patients
4) More than 2.0 mg/dl Serum creatinine levels
5) Severe interstitial lung disease
6) Coronary artery disease
7) The patients can not walk by themself.
8) The patients who have taken medications for PAH treatment drugs including the pill PGI2, endothelin receptor antagonists, phosphoesterase inhibitors-5, and intravenous epoprostenol
9) Inappropriate patients due to other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoaki Murohara
Organization Nagoya University Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 65 Tsurumai-cho, Shouwa-ku
TEL 052-744-2147
Email murohara@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Hirashiki
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Medicine in Cardiopulmonary Disease
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya
TEL 052-744-0388
Homepage URL
Email hirasiki@med.nagoya-u.ac.jp

Sponsor
Institute Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大垣市民病院(岐阜)、岡崎市民病院(愛知県)、公立陶生病院(愛知県)、小牧市民病院(愛知県)、社会保険中京病院(愛知県)、名古屋医療センター(愛知県)、名古屋第一赤十字病院(愛知県)、名古屋第二赤十字病院(愛知県)、安城更生病院(愛知県)、豊橋市民病院(愛知県),トヨタ記念病院(愛知県)、愛知医科大学(愛知県)、四日市市民病院(三重県)

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information Patients are regularly seen in the outpatient clinic at 3 monthly intervals depending on clinical stability. Follow-up examinations include clinical and functional assessment, regular cardiopulmonary exercise testing. The following treatment goals were defined:, a peak oxygen uptake >15 mL/min/kg and a peak systolic blood pressure during exercise >120 mmHg. Patients were considered clinically stable when both treatment goals were reached. For patients with newly diagnosed PAH in functional class III and IV, was considered first-line treatment.
In patients who did not reach one or more of these treatment goals on two consecutive visits, combination therapy was initiated according to a predefined algorithm. When treatment goals were not met with endothelin receptor antagonists alone, phosphodiesterase type-5 inhibitors was the preferred combination partner, followed by the addition of other medication, if needed. Intravenous epoprosterol and lung transplantation were considered only for patients not reaching the predefined goals with combination treatment.

Historical control group was defined as empiric therapy.The time period was between January 2005 and July 2011.
We evaluated whether combination therapy by using cardiopulmonary exercise testing is superior to empiric therapy in patients with pulmonary arterial hypertension.

Management information
Registered date
2011 Year 08 Month 15 Day
Last modified on
2015 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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