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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

Page last updated: August 23, 2015

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