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



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:July 2012
End Date:December 2014
Contact:Antonio Abbate
Email:aabbate@vcu.edu

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

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.

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.

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
We found this trial at
1
site
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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