Ventricular Arrhythmias in Uremic Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856400
• Other study ID #: 09-053
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: January 31, 2014
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

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