Phase 2 N=18 Randomized Triple-blind Treatment

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

Cardiac Allograft Vasculopathy

Bottom Line

View on ClinicalTrials.gov: NCT01186250 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Insulin Levels Area Under Curve(AUC) — -47.7; 10.7 h*pmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pioglitazone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Levels Area Under Curve(AUC)	-47.7; 10.7	—
SECONDARY Change in Intimal Volume	12.2; -26.8	—
SECONDARY Change in Levels of Fasting Glucose at Baseline and 1 Year	2.1; 11	—
SECONDARY Change From Baseline in TG/HDL Ratio at One Year	-0.03; -1.2	—
SECONDARY Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)	-0.01; -0.02	—
SECONDARY Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.	-0.05; -0.02	—
SECONDARY Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year	-3; 2	—

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.

Eligibility Criteria

Inclusion Criteria

Heart transplant recipients, years 1-4 post-transplant
Age >= 18 years
Fasting TG/HDL ratio>=3.0 or Fasting TG>=150 mg/dL

Exclusion Criteria

Diabetes mellitus
Severe liver dysfunction (ALT>=2.5 x upper limit of normal)
Severe renal dysfunction (GFR<30 or Stage IV CKD)
Moderate-severe fluid retention
Clinical or echocardiographic signs of left ventricular dysfunction
Contraindication to coronary angiography and/or IVUS

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01186250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.