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Trial record 88 of 157 for:    Idiopathic Dilated Cardiomyopathy

The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution

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ClinicalTrials.gov Identifier: NCT00741156
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Kyong-Jin Lee, The Hospital for Sick Children

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Congestive Cardiomyopathy
Intervention Drug: Enalaprilat
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enalaprilat
Hide Arm/Group Description Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Enalaprilat
Hide Arm/Group Description Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
12
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
2.3  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female NA [1] 
Male NA [1] 
[1]
SEX WAS NOT IDENTIFIED
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 12 participants
12
1.Primary Outcome
Title Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat
Hide Description [Not Specified]
Time Frame Baseline and after enalaprilat
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Systemic Blood Flow Baseline Systemic Blood Flow After Enalaprilat Pulmonary Blood Flow Baseline Pulmonary Blood Flow After Enaliprilat Cerebral Blood Flow Baseline Cerebral Blood Flow After Enalaprilat
Hide Arm/Group Description:
Systemic blood flow in baseline condition
Systemic blood flow 20 minutes after enalaprilat
Pulmonary blood flow baseline condition
Pulmonary blood flow 20 minutes after enalaprilat
Cerebral blood flow at baseline
Cerebral blood flow 20 minutes after enalaprilat
Overall Number of Participants Analyzed 12 12 12 12 12 12
Median (Inter-Quartile Range)
Unit of Measure: l/min/m2
1.4
(0.9 to 1.8)
1.8
(1.0 to 2.2)
1.9
(1.8 to 2.9)
1.9
(1.6 to 2.5)
1.9
(1.6 to 2.9)
1.8
(1.6 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Systemic Blood Flow Baseline, Systemic Blood Flow After Enalaprilat
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat
Hide Description Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat
Time Frame Baseline and after enalaprilat
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Systemic Resistance at Baseline Systemic Resistance After Enalaprilat Pulmonary Resistance at Baseline Pulmonary Resistance After Enalaprilat Cerebral Resistance at Baseline Cerebral Resistance After Enalaprilat
Hide Arm/Group Description:
systemic resistance in baseline condition
systemic resistance is measured after enalaprilat
pulmonary resistance at baseline is measured
pulmonary resistance is measured after enalaprilat
cerebral resistance is measured in baseline condition
cerebral resistance is measured after enalaprilat
Overall Number of Participants Analyzed 12 12 12 12 12 12
Median (Full Range)
Unit of Measure: Wood units per metre squared
40.94
(26.63 to 67.83)
20.26
(16.5 to 28.16)
2.87
(1.03 to 4.47)
2.54
(0.49 to 4.76)
24.07
(15.79 to 38.1)
17.32
(13.57 to 21.79)
Time Frame 24 hours
Adverse Event Reporting Description during cardiac catheterization monitoring period.
 
Arm/Group Title Enalaprilat
Hide Arm/Group Description Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
All-Cause Mortality
Enalaprilat
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enalaprilat
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enalaprilat
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kyong-Jin Lee
Organization: The Hospital for Sick Children
Phone: 416-813-7326
EMail: kyong-jin.lee@sickkids.ca
Layout table for additonal information
Responsible Party: Kyong-Jin Lee, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00741156     History of Changes
Other Study ID Numbers: 1000012255
First Submitted: August 25, 2008
First Posted: August 26, 2008
Results First Submitted: July 26, 2013
Results First Posted: December 18, 2015
Last Update Posted: December 18, 2015