Clinical trial NCT01856400: Ventricular Arrhythmias in Uremic Cardiomyopathy
Official title: Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Keywords: ventricular arrythmias
SERCA2a
Chronic Kidney Disease
microvolt T wave alternans
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis Patients Uremic Patients Diastolic dysfunction

Brief summary: 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.

Detailed description: This study will test the hypothesis that patients with uremic cardiomyopathy have reduced levels of SERCA2a protein compared to those with normal kidney function. We propose that such a correlation will provide convincing evidence that these patients,have a defective redistribution in intracellular calcium handling as an explanation for their increase risk in sudden cardiac death an fatal arrhythmias. To achieve our specific aims: 1) we will screen patients with end stage renal disease (ESRD) going for certain vascular procedures. 2) obtain an echocardiogram on these patients including only those with isolated diastolic dysfunction or LVH. 3) Patients who has diastolic dysfunction or LVH will be assessed for underlying microvolt (TWA) 4) vessel and skin tissue on these patients will be collected for SERCA2a quantification.

Eligibility criteria: 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

Primary outcomes:
measure: Molecular basis of ventricular arrythmias in uremic cardiomyopathy
timeFrame: At time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: SIUH
name: Suzanne El-Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References: