Trial Outcomes & Findings for Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy (NCT NCT01935622)

NCT ID: NCT01935622

Last Updated: 2014-08-20

Results Overview

Interval change in peak VO2 measured at cardiopulmonary test

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2014-08-20

Participant Flow

Participant milestones

Measure	Doxycycline 100 mg Doxycycline 100 mg twice daily for 14 days Doxycycline	Doxycycline 20 mg Doxycycline 20 mg twice daily for 14 days Doxycycline	Placebo Placebo placebo
Overall Study STARTED	3	3	4
Overall Study COMPLETED	1	1	4
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy

Baseline characteristics by cohort

Measure	Doxycycline 100 mg n=3 Participants Doxycycline 100 mg twice daily for 14 days Doxycycline	Doxycycline 20 mg n=3 Participants Doxycycline 20 mg twice daily for 14 days Doxycycline	Placebo n=4 Participants Placebo placebo	Total n=10 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	58 years n=7 Participants	54 years n=5 Participants	54 years n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: 14 days

Interval change in peak VO2 measured at cardiopulmonary test

Outcome measures

Measure	Doxycycline 100 mg n=3 Participants Doxycycline 100 mg twice daily for 14 days Doxycycline	Doxycycline 20 mg n=3 Participants Doxycycline 20 mg twice daily for 14 days Doxycycline	Placebo n=4 Participants Placebo placebo
Peak Aerobic Exercise Capacity	NA (MEDIAN) (No data analysis conducted. Insufficient enrollment)	NA (MEDIAN) (No data analysis conducted. Insufficient enrollment)	NA (MEDIAN) (No data analysis conducted. Insufficient enrollment)

Adverse Events

Doxycycline 100 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Doxycycline 20 mg

Serious events: 0 serious events

Other events: 1 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

Measure	Doxycycline 100 mg n=3 participants at risk Doxycycline 100 mg twice daily for 14 days Doxycycline	Doxycycline 20 mg n=3 participants at risk Doxycycline 20 mg twice daily for 14 days Doxycycline	Placebo n=4 participants at risk Placebo placebo
Cardiac disorders Hypotension	0.00% 0/3	33.3% 1/3 • Number of events 1	0.00% 0/4

Additional Information

Antonio Abbate

Virginia Commonwealth University

Phone: 8048280513

Email: aabbate@vcu.edu

Results disclosure agreements

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