Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy (DOXY-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01935622
First received: August 23, 2013
Last updated: September 4, 2013
Last verified: August 2013

August 23, 2013
September 4, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
Peak aerobic exercise capacity [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Interval change in peak VO2 measured at cardiopulmonary test
Same as current
Complete list of historical versions of study NCT01935622 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Non-ischemic Cardiomyopathy
  • Systolic Heart Failure (NYHA II-III)
  • Drug: Doxycycline
  • Drug: placebo
  • Experimental: Doxycycline 100 mg
    Doxycycline 100 mg twice daily for 14 days
    Intervention: Drug: Doxycycline
  • Experimental: Doxycycline 20 mg
    Doxycycline 20 mg twice daily for 14 days
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Antonio Abbate aabbate@vcu.edu
United States
 
NCT01935622
VCU HM14393
No
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Not Provided
Virginia Commonwealth University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP