Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-ischemic Cardiomyopathy; Systolic Heart Failure (NYHA II-III)
Intervention: Doxycycline (Drug); placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): Antonio Abbate, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University
Summary
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.
Clinical Details
Official title: Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Peak Aerobic Exercise Capacity
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: July 2012
Last updated: August 19, 2014
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