Heart Failure Clinical Trial
Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Richmond Virginia, 23298, United States
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