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

Trial ID or NCT#

NCT01186250

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

Hannah Valantine
Hannah Valantine
Cardiologist
Professor of Medicine (Cardiovascular)

Contact us to find out if this trial is right for you.

Contact

Nicole Constantz, BSc
650-724-4740

View on ClinicalTrials.gov