Status:
COMPLETED
Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
Lead Sponsor:
Stanford University
Conditions:
Cardiac Allograft Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the benefit of using the FDA-approved insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives of this project are to (1)...
Detailed Description
CAV, a rapidly progressive obliterative disease involving the graft coronary arteries, is the leading cause of morbidity and mortality beyond the first year after heart transplantation. This common co...
Eligibility Criteria
Inclusion
- Heart transplant recipients, years 1-4 post-transplant
- Age \>= 18 years
- Fasting TG/HDL ratio\>=3.0 or Fasting TG\>=150 mg/dL
Exclusion
- Diabetes mellitus
- Severe liver dysfunction (ALT\>=2.5 x upper limit of normal)
- Severe renal dysfunction (GFR\<30 or Stage IV CKD)
- Moderate-severe fluid retention
- Clinical or echocardiographic signs of left ventricular dysfunction
- Contraindication to coronary angiography and/or IVUS
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01186250
Start Date
July 1 2010
End Date
December 1 2013
Last Update
August 18 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305