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 |
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.
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.
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
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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