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Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients

NCT01305395 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-24

No results posted yet for this study

Summary

1. Early initiation of sirolimus will prevent or delay the development of intimal thickening and subsequent graft failure.
2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV compared to treatment guided by angiography.
3. Prevention of the development and progression of intimal thickness on IVUS will prevent the development of heart failure, graft dysfunction, and cardiovascular death related to CAV.
4. Small artery elasticity predicts progression of cardiac allograft vasculopathy and is modified by sirolimus
5. Patients who have no progression of CAV will have favorable improvement in biomarkers and endothelial cells compared to patients who have progression of CAV

Conditions

  • Cardiac Allograft Vasculopathy

Interventions

DRUG

Sirolimus

Will initiate sirolimus within 6 months of heart transplant

DRUG

Sirolimus

Will start sirolimus after CAV has been diagnosed by angiogram

DRUG

Sirolimus

Will start sirolimus after CAV has been diagnosed by intravascular ultrasound

DRUG

Sirolimus

Will start sirolimus after they develop CAV by angiogram

DRUG

Sirolimus

Will start sirolimus after CAV has been diagnosed by intravascular ultrasound

Sponsors & Collaborators

Principal Investigators

  • Monica M Colvin-Adams, MD, MS · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305395 on ClinicalTrials.gov