NCT01935622

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-ischemic Cardiomyopathy
• Systolic Heart Failure (NYHA II-III)

Interventions

Type	Name	Description
DRUG	Doxycycline	Doxycycline 1 tablet every 12 hours for 14 days
DRUG	placebo	Placebo 1 tablet every 12 hours for 14 days

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-09-05
• Last updated: 2014-08-20
• Results posted: 2014-08-20

Locations

1 site across 1 country: United States