©2024 Stanford Medicine
Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
Not Recruiting
Trial ID: NCT01186250
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
Stanford Investigator(s)
Hannah Valantine
Professor of Medicine (Cardiovascular)
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
Intervention(s):
drug: Placebo
drug: Pioglitazone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nicole Constantz, BSc
650-724-4740