NCT01889992

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5.4 years

First QC Date

June 19, 2013

Last Update Submit

August 26, 2023

Conditions

Cardiac HypertrophyImmunosuppression

Keywords

Heart transplantationCardiac allograft remodelingImmunosuppressionCardiac MRIM-TOR inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (2)

  • Assess outcomes

    One year

  • Access outcomes

    One year

Other Outcomes (1)

  • Safety end points

    Three years

Study Arms (7)

Cardiac biopsy C4D stain

ACTIVE COMPARATOR

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.

Procedure: Cardiac Biopsy C4D stain

Genetic Mechanism of M-TOR

EXPERIMENTAL

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.

Genetic: Genetic Mechanism of M-TOR

Cardiac MRI

ACTIVE COMPARATOR

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.

Radiation: Cardiac MRI

Coronary Angiography with IVUS

ACTIVE COMPARATOR

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.

Procedure: Coronary angiography with IVUS

Cardiopulmonary Exercise Test (CPET)

ACTIVE COMPARATOR

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.

Other: Cardiopulmonary Exercise Test (CPET)

MTor Immunosuppression

EXPERIMENTAL

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.

Radiation: Cardiac MRIProcedure: Coronary angiography with IVUSOther: Cardiac Allograft RemodelingDrug: M-TOR Immunosuppression

Cardiac Allograft Remodeling

EXPERIMENTAL

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

Other: Cardiac Allograft Remodeling

Interventions

Cardiac MRIRADIATION

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%.

Cardiac MRIMTor Immunosuppression
Coronary angiography with IVUSPROCEDURE

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.

Coronary Angiography with IVUSMTor Immunosuppression
Cardiac Allograft RemodelingOTHER

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

Also known as: heart hypertrophy
Cardiac Allograft RemodelingMTor Immunosuppression
M-TOR ImmunosuppressionDRUG

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.

Also known as: Sirolimus
MTor Immunosuppression
Cardiac Biopsy C4D stainPROCEDURE

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.

Also known as: heart biopsy
Cardiac biopsy C4D stain
Genetic Mechanism of M-TORGENETIC

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.

Genetic Mechanism of M-TOR
Cardiopulmonary Exercise Test (CPET)OTHER

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.

Also known as: Stress test
Cardiopulmonary Exercise Test (CPET)

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (110)

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MeSH Terms

Conditions

Cardiomegaly

Interventions

SirolimusExercise Test

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Brian Lowes, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

July 1, 2013

Study Start

April 24, 2013

Primary Completion

September 27, 2018

Study Completion

September 27, 2018

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)