Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Non-ischemic Cardiomyopathy, Systolic Heart Failure (NYHA II-III)
In brief
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.
Key facts
- Study ID
- NCT01935622
- Run by
- Virginia Commonwealth University
- People needed
- 10
- Starts
- 2012-07-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2014-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Non-ischemic cardiomyopathy (LVEF<40%)
- Heart failure NYHA II-III
You may not qualify if…
- 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
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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