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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kiran Khush, Stanford University
ClinicalTrials.gov Identifier:
NCT01186250
First received: August 19, 2010
Last updated: July 8, 2016
Last verified: July 2016
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Cardiac Allograft Vasculopathy
Interventions: Drug: Pioglitazone
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pioglitazone

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo

Placebo: placebo taken daily for one year


Participant Flow:   Overall Study
    Pioglitazone     Placebo  
STARTED     9     9  
COMPLETED     8     9  
NOT COMPLETED     1     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Double-blind randomized clinical trial of pioglitazone versus placebo from 2010 to 2013 in heart transplant recipients who were 1-4 years post-transplant.Eighteen heart transplant patients aged 22 to 72 years were randomized (9 to pioglitazone, 9 to placebo)

Reporting Groups
  Description
Pioglitazone

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo

Placebo: placebo taken daily for one year

Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Placebo     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     8     16  
>=65 years     1     1     2  
Age  
[units: years]
Mean (Full Range)
  50.8  
  (23 to 72)  
  49.2  
  (22 to 72)  
  50.0  
  (22 to 72)  
Gender  
[units: participants]
     
Female     0     1     1  
Male     9     8     17  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Levels Area Under Curve(AUC)   [ Time Frame: Baseline and 1 year ]

2.  Secondary:   Change in Intimal Volume   [ Time Frame: baseline and 1 year ]

3.  Secondary:   Change in Levels of Fasting Glucose at Baseline and 1 Year   [ Time Frame: Baseline and 1 year ]

4.  Secondary:   Change From Baseline in TG/HDL Ratio at One Year   [ Time Frame: Baseline and 1 year ]

5.  Secondary:   Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)   [ Time Frame: Baseline and 1 year ]

6.  Secondary:   Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.   [ Time Frame: Baseline and 1 year ]

7.  Secondary:   Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year   [ Time Frame: Baseline and 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kiran K. Khush, MD
Organization: Stanford University
phone: 650-721-3241
e-mail: kiran@stanford.edu



Responsible Party: Kiran Khush, Stanford University
ClinicalTrials.gov Identifier: NCT01186250     History of Changes
Other Study ID Numbers: SU-05282010-6202
CTRU protocol 1314
IRB protocol 19373
Study First Received: August 19, 2010
Results First Received: June 19, 2015
Last Updated: July 8, 2016
Health Authority: United States: Institutional Review Board