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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000020386 |
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Date of registration:
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28/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension
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Scientific title:
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Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension - Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension |
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Date of first enrolment:
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1999/04/01 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023540 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Nakamura Kazufumi |
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Address:
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2-5-1 Kita-ku, Shikata-cho, Okayama
Japan |
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Telephone:
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0862357351 |
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Email:
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ichibun@cc.okayama-u.ac.jp |
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Affiliation:
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Cardiovascular Medicine |
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Name:
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Nakamura Kazufumi |
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Address:
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2-5-1 Kita-ku, Shikata-cho, Okayama
Japan |
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Telephone:
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0862357351 |
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Email:
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ichibun@cc.okayama-u.ac.jp |
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Affiliation:
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Cardiovascular Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Exclusion criteria were as follows: thromboembolic pulmonary hypertension, hemodynamic instability including cardiac index less than 2.2 L/min/m2 and systolic blood pressure less than 80mmHg, or having symptoms associated with low cardiac output at rest.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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plumonary arterial hypertension
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Intervention(s)
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Nicardipine was administered by short-time continuous infusion (1 microg/kg/min for 5 min and 2 microg/kg/min for 5 min) followed by bolus injection (5 microg/kg). Hemodynamic responses were continuously measured using a right heart catheter.Hemodynamic responses were continuously measured before, during and after administration of nicardipine using an RHC. SaO2 (saturation of arterial blood) and SPAO2 (saturation of pulmonary arterial blood) were measured to calculate cardiac output every 5 minutes.
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Primary Outcome(s)
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safety of acute vasoreactivity testing with nicardipine in PAH patients
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Secondary Outcome(s)
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Whether can acute vasoreactivity testing with nicardipine identify patients with sustained beneficial response to oral calcium channel blockers.
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Source(s) of Monetary Support
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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