Overview

This trial is active, not recruiting.

Condition heart transplant
Treatments pioglitazone, placebo
Phase phase 2
Sponsor Stanford University
Start date July 2010
End date August 2013
Trial size 32 participants
Trial identifier NCT01186250, CTRU protocol 1314, IRB protocol 19373, SU-05282010-6202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Pioglitazone
pioglitazone Actos
15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months
(Placebo Comparator)
Placebo
placebo
placebo taken daily for one year

Primary Outcomes

Measure
Insulin levels during oral glucose tolerance test
time frame: Baseline and 1 year

Secondary Outcomes

Measure
mean coronary artery plaque volume
time frame: baseline and 1 year
Change in levels of fasting glucose, lipids, ADMA, and hs-CRP
time frame: Baseline and 1 year
Change in levels of circulating markers of inflammation
time frame: Baseline and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
Principal investigator Kiran Khush
Description CAV, a rapidly progressive obliterative disease involving the graft coronary arteries, is the leading cause of morbidity and mortality beyond the first year after heart transplantation. This common complication occurs in almost half of recipients within 3 years after heart transplantation, and is associated with high rates of graft failure and mortality. Clinical care of heart transplant recipients in the current era is greatly limited by the lack of effective treatment options to prevent or retard the progression of CAV. CAV appears to be strongly associated with the state of insulin resistance, which is present in over half of heart transplant recipients and is characterized by metabolic abnormalities including glucose intolerance, dyslipidemia, endothelial dysfunction, and high levels of circulating inflammatory markers. Insulin resistance can be effectively treated with pioglitazone, a TZD compound which directly affects tissue insulin sensitivity. In this study, we will enroll 32 insulin-resistant heart transplant recipients and will randomize them to pioglitazone or placebo for a one-year period. We will determine the efficacy of pioglitazone for the treatment of insulin resistance and prevention of the development and progression of CAV after heart transplantation. The data generated from this study will provide important preliminary data for future, larger-scale clinical investigations.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Stanford University.