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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026882
Receipt No. R000030720
Scientific Title Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension.
Date of disclosure of the study information 2017/04/10
Last modified on 2021/12/09

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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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