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Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150461
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Michael A. Fifer, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertrophic Cardiomyopathy
Interventions Drug: losartan
Drug: placebo
Enrollment 20
Recruitment Details Dates of recruitment 4-07 through 3-10.
Pre-assignment Details  
Arm/Group Title Losartan 50 mg BID Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 11 9
Completed 11 9
Not Completed 0 0
Arm/Group Title Losartan 50 mg PO BID Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  90.9%
9
 100.0%
19
  95.0%
>=65 years
1
   9.1%
0
   0.0%
1
   5.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
49  (14) 54  (11) 51  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
3
  27.3%
0
   0.0%
3
  15.0%
Male
8
  72.7%
9
 100.0%
17
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.
Hide Description [Not Specified]
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan 50 mg PO BID Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Percentage change in fibrotic myocardium
-23  (45) 31  (26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg PO BID, Placebo
Comments Mann-Whitney-Wilcoxon test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
Hide Description [Not Specified]
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan 50 mg PO BID Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 9
Mean (Inter-Quartile Range)
Unit of Measure: Percentage change in LV mass
-5
(-11 to -0.9)
5
(4 to 21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg PO BID, Placebo
Comments Mann-Whitney-Wilcoxon test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan 50 PO mg BID Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Losartan 50 PO mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Losartan 50 PO mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Losartan 50 PO mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael A. Fifer, MD
Organization: Massachusetts General Hospital
Phone: 617 726-1832
EMail: mfifer@partners.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael A. Fifer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01150461    
Other Study ID Numbers: 2006P002232/7
First Submitted: June 22, 2010
First Posted: June 25, 2010
Results First Submitted: May 2, 2013
Results First Posted: September 5, 2013
Last Update Posted: September 5, 2013