Non-ischemic Cardiomyopathy, Systolic Heart Failure (NYHA II-III)
Conditions
Keywords
heart failure, non-ischemic cardiomyopathy
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.
Interventions
DRUGDoxycycline
Doxycycline 1 tablet every 12 hours for 14 days
DRUGplacebo
Placebo 1 tablet every 12 hours for 14 days
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Aerobic Exercise Capacity | 14 days | Interval change in peak VO2 measured at cardiopulmonary test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline 100 mg Doxycycline 100 mg twice daily for 14 days
Doxycycline | 3 |
| Doxycycline 20 mg Doxycycline 20 mg twice daily for 14 days
Doxycycline | 3 |
| Placebo Placebo
placebo | 4 |
| Total | 10 |
Baseline characteristics
| Characteristic | Doxycycline 100 mg | Doxycycline 20 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 52 years | 58 years | 54 years | 54 years |
| Region of Enrollment United States | 3 participants | 3 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 1 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 4 |
Outcome results
Primary
Peak Aerobic Exercise Capacity
Interval change in peak VO2 measured at cardiopulmonary test
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Doxycycline 100 mg | Peak Aerobic Exercise Capacity | NA |
| Doxycycline 20 mg | Peak Aerobic Exercise Capacity | NA |
| Placebo | Peak Aerobic Exercise Capacity | NA |