Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Pioglitazone
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Constantz, BSc
650-724-4740
Not Recruiting