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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ischemic Cardiomyopathy focused on measuring heart failure, non-ischemic cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Doxycycline 100 mg

Doxycycline 20 mg

Placebo

Arm Description

Doxycycline 100 mg twice daily for 14 days

Doxycycline 20 mg twice daily for 14 days

Placebo

Outcomes

Primary Outcome Measures

Peak Aerobic Exercise Capacity
Interval change in peak VO2 measured at cardiopulmonary test

Secondary Outcome Measures

Full Information

First Posted
August 23, 2013
Last Updated
August 19, 2014
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT01935622
Brief Title
Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Acronym
DOXY-HF
Official Title
Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
End of funding
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ischemic Cardiomyopathy, Systolic Heart Failure (NYHA II-III)
Keywords
heart failure, non-ischemic cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline 100 mg
Arm Type
Experimental
Arm Description
Doxycycline 100 mg twice daily for 14 days
Arm Title
Doxycycline 20 mg
Arm Type
Experimental
Arm Description
Doxycycline 20 mg twice daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 1 tablet every 12 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo 1 tablet every 12 hours for 14 days
Primary Outcome Measure Information:
Title
Peak Aerobic Exercise Capacity
Description
Interval change in peak VO2 measured at cardiopulmonary test
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Abbate, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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