Ventricular Arrhythmias in Uremic Cardiomyopathy

NCT01856400 | Completed DMC

• 1 other identifier: 09-053
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Keywords

ventricular arrythmias; SERCA2a; Chronic Kidney Disease; microvolt T wave alternans

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis Patients Uremic Patients Diastolic dysfunction

You may qualify if:

• 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.

You may not qualify if:

• Age less than 18 ;
• Pregnancy;
• Dilated cardiomyopathy;
• left ventricular ejection fraction (LVEF) less than or equal to 50%;
• Patients on digoxin.
• antiarrhytmic medications;
• baseline electrolyte abnormalities;
• Atrial fibrillation;
• Bundle branch block

Sponsors & Collaborators

• Northwell Health: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood vessel tissue sample

MeSH Terms

Conditions

Cardiomyopathies; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne El-Sayegh, MD

  SIUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)