High-Resolution 12-lead 48-hours continuous ECG from end-stage renal disease Patients: during and after hemodialysis session.

IDENTIFICATION : E-HOL-12-0051-016

Study Design:

The goal of study from which these ECGs were recorded was to test the hypothesis that measurement of cardiac repolarization heterogeneity in response to dialysis, can be used to stratify End Stage Renal Disease (ESRD)patients in terms of risk for sudden arrhythmic death and thereby determine which patients may benefit most from ICD placement.

Fifty-one ESRD patients with significant risk for sudden arrhythmic death were enrolled in one University of Rochester affiliated out-patient dialysis centers. Financial incentive was offered to patients for their time and effort. Information about patient cardiac history and current drug therapies was recorded under HIPPA regulation. After the consent forms was communicated and signed, the patients entered the protocol during their next dialysis session. The study design includes 3 periods: A, baseline; B, HD period; C: post-HD. Clinical information such as age, gender, BMI and number of months on dialysis are recorded as well. .

The figure below provides information related to the study characteristics: the upper panel includes the list of clinical parameters measured during the study and availble in the THEW in addtion to age, gender and list of medication taken by the patient.proto

Enrollment criteria

End stage renal disease (ESRD) patients with high risk for cardiac arrhythmias and sudden cardiac death.

Age greater than 40 years AND
Confirmed history of hypertension requiring treatment OR 
Confirmed history of diabetes requiring treatment 
Exclusion criteria
Subject with class I  antiarrhythmic, according to cardiologist evaluation 
Subject with pacemaker 
Subject with ICD device 
Subject with cardiac resynchronization therapy (CRT) device 
Subject has a history of chronic atrial fibrillation 
Female subject of childbearing potential not using medically prescribed contraceptive measures. 
Subject participating in other clinical trails 
Subject unable to cooperate with the protocol due to dementia, psychological, or other related reason. 
Subject who refuses to sign the consent for participation. 

Study Population:

Number of patients enrolled : N=51
Enrollment: 2/13/2009 to 06/18/2010
Duration of the study: 6 months
Patient follow-up: 13 months after completion of enrollment  
Number of deaths: 11 patients (8 patients completed the study, 4 had cardiac-related death)

ECG Number of Leads: 12 lead standard configuration

ECG Sampling Frequency : 1000Hz

ECG Amplitude Resolution: 0.5 uV

File Naming Convention: Each filename is composed by a unique "ID".

Clinical Information: This database includes hundreds of clinical factors related to the hemodialysis setup, Information about patients blood pressure, medication, electrolytes and many more are provided in this data base. A complete list of the recorded factors is provided in a pdf file (click here to download). Importantly, the non-HIPAA compliant infromation described in this document have been excluded from the clinical dataset.