Clinical trial NCT01935622: Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Official title: Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-ischemic Cardiomyopathy
Systolic Heart Failure (NYHA II-III)
Keywords: heart failure
non-ischemic cardiomyopathy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Peak Aerobic Exercise Capacity
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Antonio Abbate, M.D.
role: PRINCIPAL_INVESTIGATOR
References: