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

NCT01186250 | Completed Phase 2 Results DMC

• 3 other identifiers: SU-05282010-6202CTRU protocol 1314IRB protocol 19373
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Allograft Vasculopathy

Keywords

cardiac allograft vasculopathy; pioglitazone; insulin resistance; heart transplant

Outcome Measures

Primary Outcomes (1)

• Insulin Levels Area Under Curve(AUC)

  Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.

  Baseline and 1 year

Secondary Outcomes (6)

• Change in Intimal Volume

  baseline and 1 year

• Change in Levels of Fasting Glucose at Baseline and 1 Year

  Baseline and 1 year

• Change From Baseline in TG/HDL Ratio at One Year

  Baseline and 1 year

• Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)

  Baseline and 1 year

• Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.

  Baseline and 1 year

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

Pioglitazone

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pioglitazone DRUG

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

Also known as: Actos

Pioglitazone

Placebo DRUG

placebo taken daily for one year

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kiran K. Khush, MD
• Organization: Stanford University

kiran@stanford.edu

650-721-3241

Study Officials

• Kiran Khush

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07

Locations

US (1)