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Cardiac Allograft Remodeling and Effects of Sirolimus (CAR)

Primary Purpose

Cardiac Hypertrophy, Immunosuppression

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cardiac MRI
Coronary angiography with IVUS
Cardiac Allograft Remodeling
M-TOR Immunosuppression
Cardiac Biopsy C4D stain
Genetic Mechanism of M-TOR
Cardiopulmonary Exercise Test (CPET)
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Hypertrophy focused on measuring Heart transplantation, Cardiac allograft remodeling, Immunosuppression, Cardiac MRI, M-TOR inhibitor

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult cardiac transplant recipients undergoing heart transplantation at UNMC/TNMC.

Exclusion Criteria:

  • Adult cardiac transplant recipients with acute rejection (ISHLT R> grade 2) or acute infection.

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Cardiac biopsy C4D stain

Genetic Mechanism of M-TOR

Cardiac MRI

Coronary Angiography with IVUS

Cardiopulmonary Exercise Test (CPET)

MTor Immunosuppression

Cardiac Allograft Remodeling

Arm Description

A procedure that removes a very small sample of your heart muscle so that it can be evaluated in the lab. This procedure may be done to determine the cause of cardiac myopathy (a weakened heart muscle) or to check for rejection after a heart transplant.

To identify the molecular and genetic mechanisms associated with development of early post-transplant CAR, and to evaluate the impact of mTOR-inhibitor Sirolimus on this process. Sirolimus dosage is based on blood levels.

Cardiac Magnetic Resonance Imaging (MRI) produces no side effects from the magnetic fields and radio waves and doesn't carry a risk of cancer or birth defects. Serious reactions to the special contrast dyes used for MRI are very rare. The MRI examination poses almost no risk to the average patient when appropriate safety guidelines are followed, however side effects are possible and include headache, nausea, dizziness, change in taste and allergic reaction. Such reactions usually are mild and easily controlled by medication.

Coronary angiography is a test that uses dye and special x rays to show the insides of your coronary arteries. The coronary arteries supply oxygen-rich blood to your heart. Intravascular ultrasound is a test that uses sound waves to see inside blood vessels. This article discusses intravascular ultrasound to see inside the coronary arteries, the blood vessels that supply the heart.

Is a highly sensitive, non-invasive stress test. It is considered a stress test because the exercise stresses your body's systems by making them work faster and harder. A disease or condition that affects the heart, lungs or muscles will limit how much faster and harder these systems can work. A CPET assesses how well the heart, lungs, and muscles are working individually, and how these systems are working in unison. Your heart and lungs work together to deliver oxygen to your muscles, where it is used to make energy, and to remove carbon dioxide from your body.

Sirolimus Sirolimus dosage is based on blood levels. To assess the potential of mTOR immunosuppressant Sirolimus in attenuation of CAR in HTx recipients and therefore, improve pre-existing cardiac allograft function, vasculopathy, and exercise capacity.

A surgical procedure in wich a diseased heart is replaced with a healthy heart from a deceased person.

Outcomes

Primary Outcome Measures

Assessment in left ventricular hypertrophy
The primary end point will be the change from baseline in LV mass indexed to height in meters 2.7 and LV concentricity as assessed by MRI during 12 months of the treatment.

Secondary Outcome Measures

Assess outcomes
The secondary end points will be changes from baseline in LV function.
Access outcomes
Exercise performance (peak VO2, equivalent for carbon dioxide (VE/VCO2)and coronary vessel intimal thickening.

Full Information

First Posted
June 19, 2013
Last Updated
August 26, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01889992
Brief Title
Cardiac Allograft Remodeling and Effects of Sirolimus
Acronym
CAR
Official Title
Cardiac Allograft Remodeling and Effects of Sirolimus on Its Progression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left University and project not continued
Study Start Date
April 24, 2013 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cardiac allograft remodeling causes poor quality of life, allograft failure and increased mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its progression are poorly defined and there is a need for effective interventions.This is a multi-factorial phenomenon, associated with various immunological and non-immunological factors. Animal studies suggest M-TOR inhibition attenuates cardiac allograft remodeling secondary to down-regulation of M-TOR downstream targets and increased autophagy. There is a paucity of data regarding effect of Sirolimus, a M-TOR inhibitor, on human heart remodeling. This aim of the proposal to identify the prevalence of cardiac allograft remodeling on current immunosuppressive strategies and determine risk factors for its development. It will also identify molecular pathways associated with cardiac allograft remodeling and determine the impact of Sirolimus on these pathways.
Detailed Description
Heart transplantation has become a well-established treatment option for patients with end-stage heart disease and currently has a one-year survival rate of 90%, a five-year survival rate of 70%, and 10-year survival rate of 50%. The introduction of anti-rejection treatment thirty years ago with drugs known as calcineurin inhibitors have resulted in a significant improvement in the survival of heart transplant recipients. However, most of this improvement occurs during the first year after transplantation. Beyond the first year, the mortality rate of heart transplant recipients has not changed, which indicates that the causes of late complications have not been affected in the last three decades by improvements in post-transplant care. It becomes apparent that in order to improve the late outcomes, the focus in heart transplant research needs to be shifted to the prevention and the treatment of late complications. Cardiac allograft remodeling (CAR), or changes in heart's geometric pattern, is one of the common complications after heart transplantation and often inflicts poor quality of life, heart failure, and decreased survival. The risk factors and mechanism for the development and progression of CAR are poorly defined, and there is no effective treatment for this condition. In the proposed study, we will identify the prevalence, risk factors, and effect of CAR on physical capacity, cardiac vascular disease, and patient survival after a heart transplant. For assessment of heart geometry, we will use cardiac magnetic resonance imaging (CMRI), a techniques used to visualize the internal structures of the body in detail. CMRI is considered as being a "gold standard" for evaluating the heart's structure and function. We will also evaluate the molecular and genetic markers associated with development and progression of CAR after heart transplantation. The drug Sirolimus, a new anti-rejection agent, can be used in place of calcineurin inhibitors after heart transplantation. Recent experimental and animal studies indicate that Sirolimus can attenuate the changes in the heart's geometry after a transplant (i.e., CAR) and improve heart function. We will assess the effect of Sirolimus on CAR in humans and will evaluate molecular and genetic markers associated with this effect. It is our goal to provide an important insight into the nature of CAR after heart transplantation and its response to new anti-rejection drug Sirolimus. This information will have a significant impact on the treatment of heart transplant recipients and thus improve quality of life and prolong survival after heart transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Hypertrophy, Immunosuppression
Keywords
Heart transplantation, Cardiac allograft remodeling, Immunosuppression, Cardiac MRI, M-TOR inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac biopsy C4D stain
Arm Type
Active Comparator
Arm Description
A procedure that removes a very small sample of your heart muscle so that it can be evaluated in the lab. This procedure may be done to determine the cause of cardiac myopathy (a weakened heart muscle) or to check for rejection after a heart transplant.
Arm Title
Genetic Mechanism of M-TOR
Arm Type
Experimental
Arm Description
To identify the molecular and genetic mechanisms associated with development of early post-transplant CAR, and to evaluate the impact of mTOR-inhibitor Sirolimus on this process. Sirolimus dosage is based on blood levels.
Arm Title
Cardiac MRI
Arm Type
Active Comparator
Arm Description
Cardiac Magnetic Resonance Imaging (MRI) produces no side effects from the magnetic fields and radio waves and doesn't carry a risk of cancer or birth defects. Serious reactions to the special contrast dyes used for MRI are very rare. The MRI examination poses almost no risk to the average patient when appropriate safety guidelines are followed, however side effects are possible and include headache, nausea, dizziness, change in taste and allergic reaction. Such reactions usually are mild and easily controlled by medication.
Arm Title
Coronary Angiography with IVUS
Arm Type
Active Comparator
Arm Description
Coronary angiography is a test that uses dye and special x rays to show the insides of your coronary arteries. The coronary arteries supply oxygen-rich blood to your heart. Intravascular ultrasound is a test that uses sound waves to see inside blood vessels. This article discusses intravascular ultrasound to see inside the coronary arteries, the blood vessels that supply the heart.
Arm Title
Cardiopulmonary Exercise Test (CPET)
Arm Type
Active Comparator
Arm Description
Is a highly sensitive, non-invasive stress test. It is considered a stress test because the exercise stresses your body's systems by making them work faster and harder. A disease or condition that affects the heart, lungs or muscles will limit how much faster and harder these systems can work. A CPET assesses how well the heart, lungs, and muscles are working individually, and how these systems are working in unison. Your heart and lungs work together to deliver oxygen to your muscles, where it is used to make energy, and to remove carbon dioxide from your body.
Arm Title
MTor Immunosuppression
Arm Type
Experimental
Arm Description
Sirolimus Sirolimus dosage is based on blood levels. To assess the potential of mTOR immunosuppressant Sirolimus in attenuation of CAR in HTx recipients and therefore, improve pre-existing cardiac allograft function, vasculopathy, and exercise capacity.
Arm Title
Cardiac Allograft Remodeling
Arm Type
Experimental
Arm Description
A surgical procedure in wich a diseased heart is replaced with a healthy heart from a deceased person.
Intervention Type
Radiation
Intervention Name(s)
Cardiac MRI
Intervention Description
1 month post HTx, year 1 and year 2 annual post HTx eval. CMRIs completed using 1.5-Tesla Whole Body MRI system. Scout images will determine short & long-axis views of the heart. ECG-gated cine MR of 3 long axis and a contiguous short axis orientation will be obtained. T1-weighted delayed enhancement images will be obtained 10 minutes after injection of a gadolinium-based contrast agent. Measurements from each slice will be summed using the method of disks. Myocardial mass will be estimated by multiplying the myocardial wall volume at end diastole by the specific gravity of muscle (1.05gm/ml) and LV hypertrophy will be defined as LV mass indexed to height in meters 2.7 >/=35.8 g/m 2.7) (18). Delayed Gadolinium enhancement will be defined as any enhancement pattern greater than 0%.
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography with IVUS
Intervention Description
Coronary angiography is a test that uses dye and special x rays to show the insides of your coronary arteries. The coronary arteries supply oxygen-rich blood to your heart. Intravascular ultrasound is a test that uses sound waves to see inside blood vessels. This article discusses intravascular ultrasound to see inside the coronary arteries, the blood vessels that supply the heart.
Intervention Type
Other
Intervention Name(s)
Cardiac Allograft Remodeling
Other Intervention Name(s)
heart hypertrophy
Intervention Description
A surgical procedure in which a diseased heart is replaced with a healthy heart from a deceased person.
Intervention Type
Drug
Intervention Name(s)
M-TOR Immunosuppression
Other Intervention Name(s)
Sirolimus
Intervention Description
Sirolimus (INN/USAN), also known as rapamycin, is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants. It prevents activation of T cells and B-cells by inhibiting their response to interleukin-2 (IL-2). Sirolimus dosage based on blood levels.
Intervention Type
Procedure
Intervention Name(s)
Cardiac Biopsy C4D stain
Other Intervention Name(s)
heart biopsy
Intervention Description
A long, thin tube called a biopsy catheter is inserted through a vein in your neck or grion and guided through your blood vessels to your heart.
Intervention Type
Genetic
Intervention Name(s)
Genetic Mechanism of M-TOR
Intervention Description
To identify the molecular and genetic mechanisms associated with development of early post-transplant CAR, and to evaluate the impact of mTOR-inhibitor Sirolimus on this process.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Exercise Test (CPET)
Other Intervention Name(s)
Stress test
Intervention Description
The Cardiopulmonary Exercise Test is a highly sensitive, non-invasive stress test. It is considered a stress test because the exercise stresses your body's systems by making them work faster and harder. A disease or condition that affects the heart, lungs or muscles will limit how much faster and harder these systems can work. A CPET assesses how well the heart, lungs, and muscles are working individually, and how these systems are working in unison. Your heart and lungs work together to deliver oxygen to your muscles, where it is used to make energy, and to remove carbon dioxide from your body.
Primary Outcome Measure Information:
Title
Assessment in left ventricular hypertrophy
Description
The primary end point will be the change from baseline in LV mass indexed to height in meters 2.7 and LV concentricity as assessed by MRI during 12 months of the treatment.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Assess outcomes
Description
The secondary end points will be changes from baseline in LV function.
Time Frame
One year
Title
Access outcomes
Description
Exercise performance (peak VO2, equivalent for carbon dioxide (VE/VCO2)and coronary vessel intimal thickening.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Safety end points
Description
Safety end points will be SRL side effects and prevalence of acute cellular cardiac rejection (ISHLT ≥ 2R) and AMR.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult cardiac transplant recipients undergoing heart transplantation at UNMC/TNMC. Exclusion Criteria: Adult cardiac transplant recipients with acute rejection (ISHLT R> grade 2) or acute infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Lowes, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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Cardiac Allograft Remodeling and Effects of Sirolimus

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