Trial Outcomes & Findings for The Effect of Losartan in Bicuspid Aortic Valve Patients (NCT NCT01390181)

Results Overview

Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2017-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Losartan Cozaar: Angiotensin II Receptor Blocker
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Losartan Cozaar: Angiotensin II Receptor Blocker
Overall Study Lost to Follow-up	1
Overall Study Study Terminated due to Low Accrual	3

Baseline Characteristics

The Effect of Losartan in Bicuspid Aortic Valve Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Losartan n=4 Participants Cozaar: Angiotensin II Receptor Blocker
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: No participants were analyzed because the study terminated prior to data collection for final primary outcome measure.

Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.

Outcome measures

Outcome data not reported

Adverse Events

Losartan

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Losartan n=4 participants at risk Cozaar: Angiotensin II Receptor Blocker
Cardiac disorders Increase in Blood Pressure	25.0% 1/4 • Number of events 1 • 6 months (study was terminated prior to proposed completion)
Nervous system disorders Shingles	25.0% 1/4 • Number of events 1 • 6 months (study was terminated prior to proposed completion)
Cardiac disorders Cardiace Disorder	25.0% 1/4 • Number of events 1 • 6 months (study was terminated prior to proposed completion)
General disorders Fatigue	25.0% 1/4 • Number of events 1 • 6 months (study was terminated prior to proposed completion)
Musculoskeletal and connective tissue disorders Fall	25.0% 1/4 • Number of events 1 • 6 months (study was terminated prior to proposed completion)

Additional Information

Anna Booher

Grand Traverse Heart Associates

Phone: 231 935-5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place