UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026882 |
|---|---|
| Receipt number | 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 11:36:10 |
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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
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
m-shigetoshi@umin.ac.jp
Sponsor or person
Institute
Department of Cardiology, Hospital Organization Okayama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030720
