Cardiomyopathy Clinical Trial
Official title:
Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy
Verified date | January 2014 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart muscle. This gene is also found in blood vessels and skin tissue. When active this gene builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible for regulating calcium levels inside your heart muscle. When this gene is not activated, studies have shown that it can lead to abnormal electrical currents in the heart that can lead to death. The investigators are conducting this study to prove that SERCA2a gene is inactive in patients with kidney disease. Scientists found that patient at risk for abnormal electrical currents in the heart can be tested by what they called "microvolt Twave alternans." This is a very delicate machine much more sensitive than a regular electrocardiogram that you do at the cardiology office.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age 18 years or older - Patients with stage 5 CKD or ESRD and those with normal CKD will be considered as possible candidates if admitted for one of the following vascular procedures - coronary artery bypass grafting, or vascular bypass surgery, or arteriovenous fistula creation, or arteriovenous graft surgery. - The aforementioned patients will be included if they have LVH or diastolic dysfunction and a normal LVEF on echocardiogram within one year of their scheduled surgery. Exclusion Criteria: 1. Age less than 18 ; 2. Pregnancy; 3. Dilated cardiomyopathy; 4. left ventricular ejection fraction (LVEF) less than or equal to 50%; 5. Patients on digoxin. 6. antiarrhytmic medications; 7. baseline electrolyte abnormalities; 8. Atrial fibrillation; 9. Bundle branch block |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Staten Island University Hospital | Staten Island | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Molecular basis of ventricular arrythmias in uremic cardiomyopathy | To assess the expression of SERCA2a gene expression in Uremic Cardiomyopathy patients to see if the degree of expression is implicated in ventricular arrythmias | At time of surgery | No |
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