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Ventricular Arrhythmias in Uremic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856400
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : February 3, 2014
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Suzanne El-Sayegh, Northwell Health

Tracking Information
First Submitted Date May 14, 2013
First Posted Date May 17, 2013
Last Update Posted Date February 3, 2014
Study Start Date January 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01856400 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Ventricular Arrhythmias in Uremic Cardiomyopathy
Official Title Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
blood vessel tissue sample
Sampling Method Non-Probability Sample
Study Population Hemodialysis Patients Uremic Patients Diastolic dysfunction
Condition Cardiomyopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 31, 2014)
Original Estimated Enrollment
 (submitted: May 16, 2013)
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01856400
Other Study ID Numbers 09-053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Suzanne El-Sayegh, Northwell Health
Study Sponsor Northwell Health
Collaborators Icahn School of Medicine at Mount Sinai
Principal Investigator: Suzanne El-Sayegh, MD SIUH
PRS Account Northwell Health
Verification Date January 2014