Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001965
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Cyclosporine A to Treat Hypertrophic Cardiomyopathy HCM
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Double Blind Placebo Controlled Study of Cyclosporin A in Patients With Left Ventricular Hypertrophy Caused by Sarcomeric Gene Mutations
Status:
COMPLETED
Status Verified Date:
1999-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic cardiomyopathy HCM a condition in which the heart muscle thickens The thickened muscle can impair the hearts pumping action or decrease its blood supply or both Various symptoms such as chest pain shortness of breath fatigue and palpitations may result In animal studies cyclosporine prevented heart muscle from thickening in mice that had been engineered to develop thick hearts
Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and this protocol Screening tests include blood tests echocardiogram to measure heart thickness Holter monitor to record heartbeats treadmill exercise test and various imaging tests including a thallium scan radionuclide angiography magnetic resonance imaging MRI and cardiac catheterization to examine heart function and blood supply
Patients admitted to the study will be randomly assigned to take either cyclosporine tablets or a placebo a look-alike tablet with no active ingredient twice a day for 6 months During a brief hospital stay at the start of the study blood samples will be taken to measure cyclosporine levels After discharge heart rate and blood pressure will be checked and blood tests done during follow-up visits once a week for 2 weeks and then every two weeks until the end of the 6-month treatment period At that time patients will be hospitalized a second time for repeat tests to determine the effects of the drug on the heart condition They include thallium scan radionuclide angiogram MRI treadmill exercise test cardiac catheterization and echocardiogram An echocardiogram and MRI will be repeated 1 year after the start of the study to evaluate long term effects of the drug if any
Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and this protocol Screening tests include blood tests echocardiogram to measure heart thickness Holter monitor to record heartbeats treadmill exercise test and various imaging tests including a thallium scan radionuclide angiography magnetic resonance imaging MRI and cardiac catheterization to examine heart function and blood supply
Patients admitted to the study will be randomly assigned to take either cyclosporine tablets or a placebo a look-alike tablet with no active ingredient twice a day for 6 months During a brief hospital stay at the start of the study blood samples will be taken to measure cyclosporine levels After discharge heart rate and blood pressure will be checked and blood tests done during follow-up visits once a week for 2 weeks and then every two weeks until the end of the 6-month treatment period At that time patients will be hospitalized a second time for repeat tests to determine the effects of the drug on the heart condition They include thallium scan radionuclide angiogram MRI treadmill exercise test cardiac catheterization and echocardiogram An echocardiogram and MRI will be repeated 1 year after the start of the study to evaluate long term effects of the drug if any
Detailed Description:
Hypertrophic cardiomyopathy HCM is a genetic cardiac disease characterized by marked increase in cardiac mass caused by proliferationhypertrophy of several cell types myocytes fibroblasts smooth muscle cells and endothelial cells There is often associated left ventricular LV diastolic dysfunction and myocardial ischemia The severity of the LV hypertrophy diastolic dysfunction and myocardial ischemia are important determinants of clinical course In several animal models of LV hypertrophy calcineurin has been implicated in the development of myocardial hypertrophy leading to cardiac dilatation and failure Inhibitors of calcineurin Cyclosporin A and FK506 have been shown to prevent the development of cardiac hypertrophy in these animal models where cardiac hypertrophy is related to sarcomeric dysfunction We propose to study the ability of Cyclosporin A CsA to reduce LV mass and to improve symptoms LV diastolic function and myocardial perfusion in HCM caused by sarcomeric gene mutations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0034 | None | None | None |