UMIN-CTR Clinical Trial

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
Email	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
Email	hirasiki@ncgg.go.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	Nagoya Graduate Scool of Medicine
Address	65 Tsurumai Showa, Nagoya
Tel	+81527442147
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007294