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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kiran Khush, Stanford University
ClinicalTrials.gov Identifier:
NCT01186250
First received: August 19, 2010
Last updated: March 26, 2013
Last verified: March 2013

August 19, 2010
March 26, 2013
July 2010
August 2013   (final data collection date for primary outcome measure)
Insulin levels during oral glucose tolerance test [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186250 on ClinicalTrials.gov Archive Site
  • mean coronary artery plaque volume [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Change in levels of fasting glucose, lipids, ADMA, and hs-CRP [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
  • Change in levels of circulating markers of inflammation [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Transplant
  • Drug: Pioglitazone
    15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months
    Other Name: Actos
  • Drug: Placebo
    placebo taken daily for one year
  • Active Comparator: Arm 1
    Pioglitazone
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: Arm 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186250
SU-05282010-6202, CTRU protocol 1314, IRB protocol 19373
Yes
Kiran Khush, Stanford University
Stanford University
Not Provided
Principal Investigator: Kiran Khush Stanford University
Stanford University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP