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

This study has been terminated.
(End of funding)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01935622
First received: August 23, 2013
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: June 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Non-ischemic Cardiomyopathy
Systolic Heart Failure (NYHA II-III)
Interventions: Drug: Doxycycline
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Doxycycline 100 mg

Doxycycline 100 mg twice daily for 14 days

Doxycycline

Doxycycline 20 mg

Doxycycline 20 mg twice daily for 14 days

Doxycycline

Placebo

Placebo

placebo


Participant Flow:   Overall Study
    Doxycycline 100 mg     Doxycycline 20 mg     Placebo  
STARTED     3     3     4  
COMPLETED     1     1     4  
NOT COMPLETED     2     2     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
(No data analysis conducted. Insufficient enrollment)

Reporting Groups
  Description
Doxycycline 100 mg

Doxycycline 100 mg twice daily for 14 days

Doxycycline

Doxycycline 20 mg

Doxycycline 20 mg twice daily for 14 days

Doxycycline

Placebo

Placebo

placebo

Total Total of all reporting groups

Baseline Measures
    Doxycycline 100 mg     Doxycycline 20 mg     Placebo     Total  
Number of Participants  
[units: participants]
  3     3     4     10  
Age  
[units: years]
Median ( Full Range )
  52  
  ( 48 to 55 )  
  58  
  ( 55 to 59 )  
  54  
  ( 49 to 60 )  
  54  
  ( 48 to 60 )  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     3     4     10  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     0     0     2     2  
Male     3     3     2     8  
Region of Enrollment  
[units: participants]
       
United States     3     3     4     10  



  Outcome Measures

1.  Primary:   Peak Aerobic Exercise Capacity   [ Time Frame: 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
(No data analysis conducted. Insufficient enrollment)


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Antonio Abbate
Organization: Virginia Commonwealth University
phone: 8048280513
e-mail: aabbate@vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01935622     History of Changes
Other Study ID Numbers: VCU HM14393
Study First Received: August 23, 2013
Results First Received: June 20, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board