Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
NCT ID: NCT01935622
Last Updated: 2014-08-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2012-07-31
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Doxycycline 100 mg
Doxycycline 100 mg twice daily for 14 days
Doxycycline
Doxycycline 1 tablet every 12 hours for 14 days
Doxycycline 20 mg
Doxycycline 20 mg twice daily for 14 days
Doxycycline
Doxycycline 1 tablet every 12 hours for 14 days
Placebo
Placebo
placebo
Placebo 1 tablet every 12 hours for 14 days
Interventions
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Doxycycline
Doxycycline 1 tablet every 12 hours for 14 days
placebo
Placebo 1 tablet every 12 hours for 14 days
Eligibility Criteria
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Inclusion Criteria
* Heart failure NYHA II-III
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Antonio Abbate, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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VCU HM14393
Identifier Type: -
Identifier Source: org_study_id
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