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

This study has been withdrawn prior to enrollment.
(Due in part, to reduced transplant volume and enrollment has been difficult.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305395
First Posted: February 28, 2011
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
  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

Condition Intervention
Cardiac Allograft Vasculopathy Drug: Sirolimus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Vs Late Sirolimus-Initiation Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 1. Change in maximal intimal thickness [ Time Frame: 1, 2, 3 and 4 years ]

Secondary Outcome Measures:
  • Mean maximal intima thickness [ Time Frame: 1, 2, 3, and 4 years ]
  • Percent atheroma volume [ Time Frame: 1,2,3 and 4 years ]
  • Death from CAV, death from any cause, myocardial infarction, need for percutaneous coronary intervention (PCI), number of hospitalizations, infection rates, evidence of restrictive physiology, arrhythmic event related to CAV or pulmonary hypertension [ Time Frame: at 4 years. ]
  • Change in small artery elasticity [ Time Frame: At 1, 2, 3, and 4 years ]
  • Change in endothelial progenitor cell count [ Time Frame: At 1 and 2 years ]
  • Change in biomarkers [ Time Frame: At 1 and 2 years ]

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Intervention Arm
Initiate sirolimus within 6 months of heart transplant
Drug: Sirolimus
Will initiate sirolimus within 6 months of heart transplant
Other Name: Rapamycin
Experimental: Late Intervention Arm: Group 2A
Initiate sirolimus after CAV is diagnosed by angiogram
Drug: Sirolimus
Will start sirolimus after CAV has been diagnosed by angiogram
Other Name: Rapamycin
Experimental: Retrospective Arm: Angiogram group
Start sirolimus after CAV diagnosed is by angiogram
Drug: Sirolimus
Will start sirolimus after they develop CAV by angiogram
Other Name: Rapamycin
Experimental: Late Intervention Arm: Group 2B
Start sirolimus after CAV is diagnosed by IVUS
Drug: Sirolimus
Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
Other Name: Rapamycin
Experimental: Retrospective Arm: Intravascular Ultrasound
Sirolimus after CAV is diagnosed by IVUS
Drug: Sirolimus
Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
Other Name: Rapamycin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

For Prospective Arm:

  • 18 years or older
  • Successful orthotropic heart transplant within 6 months of enrollment

Inclusion Criteria

For Retrospective Arm:

  • 18 years or older
  • Successful orthotropic heart transplant within 6 months to 3 years of enrolment
  • Less than moderate CAV by angiogram or IVUS

Exclusion Criteria

For Prospective Arm:

  • Greater than minimal baseline coronary disease
  • Chronic kidney disease with creatinine >2mg/dl
  • Baseline (1 month) ejection fraction < 50%
  • IV contrast allergy
  • Rejection within 3 months of enrollment
  • Sensitivity to sirolimus or its derivatives
  • Prior sirolimus use

Exclusion Criteria

For Retrospective Arm:

  • Significant baseline (one month) coronary artery disease (>50% in one or more vessels by angiogram or MIT >0.5 by IVUS)
  • Chronic kidney disease with creatinine >2mg/dl
  • Baseline (1 month) ejection fraction < 50%
  • IV contrast allergy
  • Rejection within 3 months prior to enrollment
  • Sensitivity to sirolimus or its derivatives
  • Prior sirolimus use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305395


Locations
United States, Minnesota
Cardiology Division, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Monica M Colvin-Adams, MD, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01305395     History of Changes
Other Study ID Numbers: 1007M85473
First Submitted: February 25, 2011
First Posted: February 28, 2011
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cardiac Allograft Vasculopathy in Heart Transplant

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs