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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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) 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

1. Heart transplant recipients, years 1-4 post-transplant

2. Age >= 18 years

3. Fasting TG/HDL ratio>=3.0 or Fasting TG>=150 mg/dL

Exclusion Criteria:

1. Diabetes mellitus

2. Severe liver dysfunction (ALT>=2.5 x upper limit of normal)

3. Severe renal dysfunction (GFR<30 or Stage IV CKD)

4. Moderate-severe fluid retention

5. Clinical or echocardiographic signs of left ventricular dysfunction

6. Contraindication to coronary angiography and/or IVUS