Non-ischemic Cardiomyopathy | Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Non-ischemic Cardiomyopathy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Systolic Heart Failure (NYHA II-III)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DoxycyclineDoxycycline 1 tablet every 12 hours for 14 days
Drug:placeboPlacebo 1 tablet every 12 hours for 14 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Doxycycline 100 mgDoxycycline 100 mg twice daily for 14 days
Doxycycline 20 mgDoxycycline 20 mg twice daily for 14 days
Start Date: July 2012
Completed Date: June 2014
Phase: Phase 2
Primary Outcome: Peak Aerobic Exercise Capacity
Study sponsors, principal investigator, and references
Principal Investigator: Antonio Abbate, M.D.
Lead Sponsor: Virginia Commonwealth University