Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cardiac Allograft Vasculopathy

In brief

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) determine if pioglitazone effectively treats insulin resistance in heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart transplantation impacts the development or progression of cardiac allograft vasculopathy (CAV), a form of chronic rejection after heart transplantation.

Key facts

Study ID

NCT01186250

Run by

Stanford University

People needed

18

Starts

2010-07-01

Expected to finish

2013-12-01

Last updated by the study team

2016-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart transplant recipients, years 1-4 post-transplant
• Age >= 18 years
• Fasting TG/HDL ratio>=3.0 or Fasting TG>=150 mg/dL

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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