UMIN-CTR Clinical Trial

Basic information
Public title	Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension.
Acronym	Effect of oxygen administration on PVR and CI in CTEPH.
Scientific Title	Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension.
Scientific Title:Acronym	Effect of oxygen administration on PVR and CI in CTEPH.
Region	Japan

Condition
Condition	chronic thromboembolic pulmonary hypertension.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of pulmonary arterial pressure and pulmonary vascular resistance before and after oxygen administration.
Key secondary outcomes	Change of cardiac index before and after oxygen administration.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Oxygen administration
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic thromboembolic pulmonary hypertension whose mean pulmonary arterial pressure is more than 25 mmHg.
Key exclusion criteria	1) Patients with ischemic heart disease. 2) Patients with severe systemic hypertension (systolic blood pressure higher than or equal to 180 mmHg and/or diastolic blood pressure higher than or equal to 110 mmHg). 3) Pregnant patients. 4) Patients with severe valvular heart disease. 5) Patients with a history of acute myocardial infarction and/or cerebral vascular disease within 6 months. 6) Patients with hypotension (systolic blood pressure lower than or equal to 85mmHg). 7) Patients with severe ventricular arrhythmia. 8) Patients with severe renal dysfunction (Serum creatinine higher than or equal to 2mg/dl). 9) Patients with severe liver dysfunction. 10) Patients with chronic inflammatory disease. 11) Patients with malignancy. 12) Patients who were considered as inadequate for enrollment by the principal investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Matsubara
Organization	National Hospital Organization Okayama Medical Center
Division name	Department of Cardiology and Clinical Science
Zip code	7011192
Address	1711-1 Tamasu, Kita-ku, Okayama, Okayama, JAPAN
TEL	086-294-9911
Email	himatsu@okayamamc.jp

Public contact
Name of contact person	1st name Masataka Middle name Last name Shigetoshi
Organization	National Hospital Organization Okayama Medical Center
Division name	Department of Cardiology
Zip code	7011192
Address	1711-1 Tamasu, Kita-ku, Okayama, Okayama, JAPAN
TEL	086-294-9911
Homepage URL
Email	m-shigetoshi@umin.ac.jp

Sponsor
Institute	Department of Cardiology, Hospital Organization Okayama Medical Center
Institute
Department

Funding Source
Organization	none
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	Institutional Review Board of the National Hospital Organization Okayama Medical Center
Address	1711-1 Tamasu, Kita-ku, Okayama, Okayama, JAPAN
Tel	086-294-9911
Email	rinsyou@okayamamc.jp

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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 10 Day

Related information
URL releasing protocol	https://doi.org/10.1016/j.jjcc.2021.09.003
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.jjcc.2021.09.003
Number of participants that the trial has enrolled	52
Results	This study included 52 consecutive patients with CTEPH. Oxygen administration significantly decreased mean PAP by 3.8 mmHg ( p < 0.001) and pulmonary vascular resistance by 0.8 Wood units ( p < 0.001). Multivariate regression analysis identified baseline mean PAP as the only significant predictor of decreased mean PAP under oxygen administration. No significant difference in oxygen effect on mean PAP was found between patients with and without vasodilators.
Results date posted	2021 Year 12 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Fifty-two patients [mean age 65.2 years, 41 women (79%)] met the study inclusion criteria. Disease duration, i.e. from symptom onset to study enrollment, was approximately 1.5 years. Twenty-five patients (48%) were in WHO functional class III/IV, and 23 patients (44%) were treated with one or more specific pulmonary vasodilators.
Participant flow	A thermodilution catheter was inserted into the pulmonary artery through the right internal jugular vein or right femoral vein. Right atrial pressure, mean PAP, pulmonary capillary wedge pressure, and mixed venous oxygen saturation were measured, and cardiac output and CI were determined by the thermodilution method at baseline, with the patient breathing ambient air. Subsequently, 5 L/min oxygen, which is our routine dose during BPA procedure, was administered by face mask for at least 10 min, and hemodynamic measurements were repeated.
Adverse events	Exposure to oxygen was well tolerated by patients without any discomfort or adverse events.
Outcome measures	The hemodynamics using right heart catheterization while breathing ambient air and with administration of 5 L/min oxygen for 10 min.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 03 Month 27 Day
Date of IRB	2015 Year 03 Month 27 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 30 Day
Date trial data considered complete	2019 Year 05 Month 30 Day
Date analysis concluded	2021 Year 08 Month 22 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 05 Day
Last modified on	2021 Year 12 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030720

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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