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

Non-ischemic Cardiomyopathy Clinical Trial

— DOXY-HF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01935622
• Other study ID #: VCU HM14393
• Status: Terminated
• Phase: Phase 2
• First received: August 23, 2013
• Last updated: August 19, 2014
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Heart Failure, Systolic
• Non-ischemic Cardiomyopathy
• Systolic Heart Failure (NYHA II-III)

Intervention

Drug:
• Doxycycline
Doxycycline 1 tablet every 12 hours for 14 days
• placebo
Placebo 1 tablet every 12 hours for 14 days

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Aerobic Exercise Capacity	Interval change in peak VO2 measured at cardiopulmonary test	14 days	Yes