Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy (DOXY-HF)
Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation.
Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects.
In this study we plan to determine the effects of Doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and ventilator efficiency measured with a cardiopulmonary test.
Systolic Heart Failure (NYHA II-III)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy|
- Peak aerobic exercise capacity [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Interval change in peak VO2 measured at cardiopulmonary test
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Doxycycline 100 mg
Doxycycline 100 mg twice daily for 14 days
Experimental: Doxycycline 20 mg
Doxycycline 20 mg twice daily for 14 days
Placebo Comparator: Placebo
In this study of Safety and Efficacy of Doxycycline in Patients with Non-Ischemic Cardiomyopathy Population, we will enroll 24 patients with a clinical diagnosis of heart failure and non-ischemic cardiomyopathy (recent imaging study documenting LV ejection fraction <50%, and no history of coronary or ischemic heart disease) in a single-center, randomized, double-blinded, placebo-controlled clinical trial with allocation 1:1:1 to Doxycycline 100 mg twice daily or Doxycycline 20 mg twice daily or Placebo for 2 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935622
|Contact: Antonio Abbatefirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Antonio Abbate email@example.com|