Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
|ClinicalTrials.gov Identifier: NCT01186250|
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Allograft Vasculopathy||Drug: Pioglitazone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: 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
Placebo Comparator: Placebo
placebo taken daily for one year
- Insulin Levels Area Under Curve(AUC) [ Time Frame: Baseline and 1 year ]Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.
- Change in Intimal Volume [ Time Frame: baseline and 1 year ]Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)
- Change in Levels of Fasting Glucose at Baseline and 1 Year [ Time Frame: Baseline and 1 year ]Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.
- Change From Baseline in TG/HDL Ratio at One Year [ Time Frame: Baseline and 1 year ]Triglyceride ratio to High Density Lipoprotien
- Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS) [ Time Frame: Baseline and 1 year ]The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.
- Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year. [ Time Frame: Baseline and 1 year ]Competitive ELISA assay in Stanford laboratory.
- Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year [ Time Frame: Baseline and 1 year ]measure of low levels of C-reactive protein to identify low but persistent levels of inflammation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186250
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kiran Khush||Stanford University|