UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006174 |
|---|---|
| Receipt number | 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 | 2022/08/30 23:36:55 |
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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 | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-0065
Address
65 Tsurumai-cho, Shouwa-ku
TEL
052-744-2147
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Hirashiki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Medicine in Cardiopulmonary Disease
Zip code
466-8550
Address
65 Tsurumai-cho, Shouwa-ku, Nagoya
TEL
052-744-0388
Homepage URL
hirasiki@ncgg.go.jp
Sponsor or person
Institute
Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
Nagoya Graduate Scool of Medicine
Address
65 Tsurumai Showa, Nagoya
Tel
+81527442147
hirasiki@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
hirasiki22f
Org. issuing International ID_1
hirasiki22f
Study ID_2
hirasiki22f
Org. issuing International ID_2
hirasiki22f
IND to MHLW
hirasiki22f
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892494/pdf/circrep-1-303.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892494/pdf/circrep-1-303.pdf
Number of participants that the trial has enrolled
129
Results
The primary endpoint was cardiovascular death. In the goal-oriented therapy group, plasma brain natriuretic peptide, mean pulmonary arterial pressure, pulmonary vascular resistance, and 6-min walk test were significantly improved at 12 months compared with baseline. Survival in the goal-oriented therapy group at 1, 2, and 3 years (97.6%, 95.2%, and 86.0%, respectively) tended to be higher than that in the conventional empiric therapy group (P=0.082).
Results date posted
| 2022 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 02 | Day |
Baseline Characteristics
We compared prognosis in PAH patients receiving goal-oriented, sequential combination therapy evaluated using cardiopulmonary exercise testing (CPX) parameters or conventional empiric therapy.
Methods and Results: The Goal-Oriented Therapy Evaluated by Cardiopulmonary Exercise Testing for Pulmonary Arterial
Hypertension (GOOD EYE) study was a multicenter, retrospective/prospective study in which a total of 129 patients with newly
diagnosed PAH were enrolled (goal-oriented sequential combination therapy, n=42; conventional empiric therapy, n=87).
Participant flow
Patients in the goal-oriented therapy group received sequential combination therapy, the efficacy of which was regularly evaluated using CPX
parameters. Patients in the conventional empiric therapy group received conventional empiric therapy.
Adverse events
No
Outcome measures
The primary endpoint was cardiovascular death. In the goal-oriented therapy group, plasma brain natriuretic peptide, mean pulmonary arterial pressure, pulmonary vascular resistance, and 6-min walk test were significantly improved at 12 months compared with baseline. Survival in the goal-oriented therapy group at 1, 2, and 3 years (97.6%, 95.2%, and 86.0%, respectively) tended to be higher than that in the
conventional empiric therapy group (P=0.082).
Plan to share IPD
We have no plan to share IPD.
IPD sharing Plan description
We have no plan to IPD sharing plan description.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 01 | Day |
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
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007294
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