ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Cardiac MRI in Heart Transplant

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03102125
Recruitment Status : Not yet recruiting
First Posted : April 5, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Paul Kim, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.

Condition or disease Intervention/treatment Phase
Heart Transplant Failure and Rejection Drug: Regadenoson Phase 4

Detailed Description:

Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 10 months. Patients will be recruited from UCSD. The investigators will specifically enroll patients with nonspecific allograft dysfunction and patients with normal graft function.

Brief protocol:

Cardiac MRI is performed. Cine images in standard views are obtained. T2 mapping sequences are performed on short axis images. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for one month after enrollment for MACE.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Nonspecific allograft dysfunction
Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
 Drug: Regadenoson
For use in stress myocardial perfusion imaging.
Other Name: Lexiscan
Experimental: Normal graft function
Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
 Drug: Regadenoson
For use in stress myocardial perfusion imaging.
Other Name: Lexiscan


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Myocardial Perfusion Reserve [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Myocardial ischemia/infarction [ Time Frame: 24 months ]
  2. Hospitalization for cardiac related causes [ Time Frame: 24 months ]
  3. Re-transplantation [ Time Frame: 24 months ]
  4. Death from cardiovascular causes [ Time Frame: 24 months ]
  5. All cause mortality [ Time Frame: 24 months ]
  6. Late gadolinium enhancement [ Time Frame: 24 months ]
  7. Mean segmental T1 values of the left ventricle [ Time Frame: 24 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Age greater than or equal to 18 years old.
  • At least three months status post heart transplantation.
  • Heart-transplant patients with normal graft function (left ventricular ejection fraction equal to or greater than 55%) and no prior history of clinically significant acute rejection episodes that required modification of the immunosuppressive regimen or cardiac allograft vasculopathy.
  • Heart-transplant patients with nonspecific allograft dysfunction (left ventricular ejection fraction equal to or less than 50% AND decrease from post-transplant baseline ejection fraction by an absolute difference of 10% or greater, no formal diagnosis of allograft vasculopathy by coronary angiogram or coronary vascular ultrasonography, and no history of prior acute rejection episodes known to have decreased left ventricular ejection fraction to or less than 50%).

Exclusion Criteria:

  • Biopsy proven acute rejection episode in the past 3 months.
  • Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months.
  • Uncontrolled obstructive ventilatory disease including asthma and COPD.
  • Second or third degree AV nodal block.
  • Sinus node dysfunction.
  • Contraindications to MRI including pacemakers or implantable cardioverter-defibrillators.
  • Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.
  • Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine will be assessed on a case-by-case basis.
  • Any invasive procedure, including endomyocardial biopsy and left coronary angiogram, performed within one week.
  • Systolic blood pressure greater than 180 or less than 85 mmHg.
  • Diastolic blood pressure greater than 120 or less than 40 mmHg.
  • Resting heart rate greater than 120 or less than 45 beats per minute.
  • Severe claustrophobia.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03102125


Contacts
Contact: Paul Kim, MD 8582460638 pjk017@ucsd.edu

Sponsors and Collaborators
Paul Kim
Astellas Pharma Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:
Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034.

Responsible Party: Paul Kim, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03102125     History of Changes
Other Study ID Numbers: 160808
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Kim, University of California, San Diego:
heart transplant, acute graft rejection, chronic graft rejection

Additional relevant MeSH terms:
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
 Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs