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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline 100 mg | Experimental | Doxycycline 100 mg twice daily for 14 days |
|
| Doxycycline 20 mg | Experimental | Doxycycline 20 mg twice daily for 14 days |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline 1 tablet every 12 hours for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Aerobic Exercise Capacity | Interval change in peak VO2 measured at cardiopulmonary test | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Abbate, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline 100 mg | Doxycycline 100 mg twice daily for 14 days Doxycycline |
| FG001 | Doxycycline 20 mg | Doxycycline 20 mg twice daily for 14 days Doxycycline |
| FG002 | Placebo | Placebo placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
(No data analysis conducted. Insufficient enrollment)
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline 100 mg | Doxycycline 100 mg twice daily for 14 days Doxycycline |
| BG001 | Doxycycline 20 mg | Doxycycline 20 mg twice daily for 14 days Doxycycline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Aerobic Exercise Capacity | Interval change in peak VO2 measured at cardiopulmonary test | Posted | Median | Inter-Quartile Range | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline 100 mg | Doxycycline 100 mg twice daily for 14 days Doxycycline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
(No data analysis conducted. Insufficient enrollment)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Abbate | Virginia Commonwealth University | 8048280513 | aabbate@vcu.edu |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| placebo | Drug | Placebo 1 tablet every 12 hours for 14 days |
|
| BG002 | Placebo | Placebo placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Doxycycline 20 mg | Doxycycline 20 mg twice daily for 14 days Doxycycline | 0 | 3 | 1 | 3 |
| EG002 | Placebo | Placebo placebo | 0 | 4 | 0 | 4 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |