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

This study has suspended participant recruitment.
(Due in part, to reduced transplant volume and enrollment has been difficult.)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01305395
First received: February 25, 2011
Last updated: March 13, 2013
Last verified: March 2013
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean maximal intima thickness [ Time Frame: 1, 2, 3, and 4 years ] [ Designated as safety issue: No ]
  • Percent atheroma volume [ Time Frame: 1,2,3 and 4 years ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Change in small artery elasticity [ Time Frame: At 1, 2, 3, and 4 years ] [ Designated as safety issue: No ]
  • Change in endothelial progenitor cell count [ Time Frame: At 1 and 2 years ] [ Designated as safety issue: No ]
  • Change in biomarkers [ Time Frame: At 1 and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: January 2016
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 25, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 28, 2014