Non-ischemic CardiomyopathyPhase 2DOXY-HFNCT01935622
Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
A Phase 2 study testing Doxycycline in people with Non-ischemic Cardiomyopathy and Systolic Heart Failure (NYHA II-III), run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ischemic Cardiomyopathy, Systolic Heart Failure (NYHA II-III)
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-ischemic cardiomyopathy (LVEF<40%)
- Heart failure NYHA II-III
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Being tested
- Doxycycline, placebo
- Keywords
- heart failure, non-ischemic cardiomyopathy
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 1 tablet every 12 hours for 14 days
placeboDrug
Placebo 1 tablet every 12 hours for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline 100 mg | Experimental | Doxycycline 100 mg twice daily for 14 days Receives: Drug: Doxycycline |
| Doxycycline 20 mg | Experimental | Doxycycline 20 mg twice daily for 14 days Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Aerobic Exercise Capacity
Interval change in peak VO2 measured at cardiopulmonary test
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: End of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Abbate, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935622
- Sponsor's protocol ID
- VCU HM14393
- Acronym
- DOXY-HF
- Status last verified
- Aug 2014
- First submitted
- 23 Aug 2013
- Last updated
- 20 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01935622
- Acronym / sponsor ID
- DOXY-HF / VCU HM14393
- Keywords
- heart failure, non-ischemic cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doxycycline 100 mg | Experimental | Drug: DoxycyclineDoxycycline 100 mg twice daily for 14 days |
| Doxycycline 20 mg | Experimental | Drug: DoxycyclineDoxycycline 20 mg twice daily for 14 days |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-ischemic cardiomyopathy (LVEF<40%)
- Heart failure NYHA II-III
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineDoxycycline 1 tablet every 12 hours for 14 days | Drug | Doxycycline 100 mg, Doxycycline 20 mg |
| placeboPlacebo 1 tablet every 12 hours for 14 days | Drug | Placebo |
Primary outcome
Peak Aerobic Exercise Capacity
Time frame: 14 days
Interval change in peak VO2 measured at cardiopulmonary test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Abbate, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline in people with Non-ischemic Cardiomyopathy and Systolic Heart Failure (NYHA II-III), run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Aerobic Exercise Capacity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.