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Ventricular Arrhythmias in Uremic Cardiomyopathy

This study has been completed.
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System Identifier:
First received: May 14, 2013
Last updated: January 31, 2014
Last verified: January 2014
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy

Resource links provided by NLM:

Further study details as provided by Suzanne El-Sayegh, North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Molecular basis of ventricular arrythmias in uremic cardiomyopathy [ Time Frame: At time of surgery ]
    To assess the expression of SERCA2a gene expression in Uremic Cardiomyopathy patients to see if the degree of expression is implicated in ventricular arrythmias

Biospecimen Retention:   Samples With DNA
blood vessel tissue sample

Enrollment: 36
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis Patients Uremic Patients Diastolic dysfunction

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01856400

United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Icahn School of Medicine at Mount Sinai
Principal Investigator: Suzanne El-Sayegh, MD SIUH
  More Information

Responsible Party: Suzanne El-Sayegh, M.D., North Shore Long Island Jewish Health System Identifier: NCT01856400     History of Changes
Other Study ID Numbers: 09-053
Study First Received: May 14, 2013
Last Updated: January 31, 2014

Keywords provided by Suzanne El-Sayegh, North Shore Long Island Jewish Health System:
ventricular arrythmias
Chronic Kidney Disease
microvolt T wave alternans

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on September 21, 2017