Trial Outcomes & Findings for Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy (NCT NCT01150461)

NCT ID: NCT01150461

Last Updated: 2013-09-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 1 year
• Results posted on: 2013-09-05

Participant Flow

Dates of recruitment 4-07 through 3-10.

Participant milestones

Measure	Losartan 50 mg BID	Placebo
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Baseline characteristics by cohort

Measure	Losartan 50 mg PO BID n=11 Participants	Placebo n=9 Participants	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	49 years STANDARD_DEVIATION 14 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	51 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Outcome measures

Measure	Losartan 50 mg PO BID n=11 Participants	Placebo n=9 Participants
Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.	-23 Percentage change in fibrotic myocardium Standard Deviation 45 • Interval -11.0 to -0.9	31 Percentage change in fibrotic myocardium Standard Deviation 26 • Interval -4.0 to 21.0

SECONDARY outcome

Timeframe: Baseline and 1 year

Outcome measures

Measure	Losartan 50 mg PO BID n=11 Participants	Placebo n=9 Participants
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.	-5 Percentage change in LV mass Inter-Quartile Range 11 • Interval -11.0 to -0.9	5 Percentage change in LV mass Inter-Quartile Range 28 • Interval 4.0 to 21.0

Adverse Events

Losartan 50 PO mg BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael A. Fifer, MD

Massachusetts General Hospital

Phone: 617 726-1832

Email: mfifer@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place