Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy

Phase 2

Terminated

• Conditions: Systolic Heart Failure (NYHA II-III); Non-ischemic Cardiomyopathy
• Interventions: Drug: Doxycycline; Drug: placebo

• Registration Number: NCT01935622
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2014-06-20
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Results First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline 20 mg	Doxycycline	Doxycycline 20 mg twice daily for 14 days
Placebo	placebo	Placebo
Doxycycline 100 mg	Doxycycline	Doxycycline 100 mg twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Peak Aerobic Exercise Capacity	14 days	Interval change in peak VO2 measured at cardiopulmonary test

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States