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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Doxycycline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycycline 100 mg<br>Doxycycline 100 mg twice daily for 14 days | Drug: Doxycycline<br>* Doxycycline 1 tablet every 12 hours for 14 days<br>|
| Experimental: Doxycycline 20 mg<br>Doxycycline 20 mg twice daily for 14 days | Drug: Doxycycline<br>* Doxycycline 1 tablet every 12 hours for 14 days<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* Placebo 1 tablet every 12 hours for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Aerobic Exercise Capacity | Interval change in peak VO2 measured at cardiopulmonary test | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, non-ischemic cardiomyopathy