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

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• Non-ischemic cardiomyopathy (LVEF<40%)

• Heart failure NYHA II-III

Exclusion Criteria:

• Age <18

• Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)

• Hospitalization for worsening HF or acute decompensated HF within the previous 12 months

• History of coronary or ischemic heart disease

• Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery

• Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing

• Active infection including chronic infection

• Active cancer (or prior diagnosis of cancer within the past 10 years)

• Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study

• Pregnancy

• Inability to give informed consent

• Other conditions limiting completion of cardiopulmonary exercise test or completion of the study