Recruiting

Observational Study

Sponsor:

Rhode Island Hospital

Code:

NCT02738749

Conditions

Death, Sudden, Cardiac

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implantable cardioverter-defibrillator (ICD)

Study Details

Brief summary:

Congestive heart failure (CHF) represents a major health care concern in the United States. Currently, risk stratification of sudden cardiac death and the need for implantable cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is suboptimal, alternative testing for risk assessment for the development of sudden cardiac death in the heart failure population is desirable.

At the genome level, the investigator has focused on the role of SCN5A gene mutations in arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk populations. This study will determine if SCN5A variant levels are predictive of appropriate ICD therapies in patients with a newly implanted ICD.

Conditions

Death, Sudden, Cardiac

Study ID

NCT02738749

Start date

Jun, 2014

Status verified date

Apr, 2017

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All patients must be greater than 18 years of age.
2. All patients must be able to give informed consent.
3. Patients must receive an ICD within 10 days for primary prevention.

Exclusion Criteria:

1. Patients less than 18 years of age.
2. History of congenital heart disease.
3. History of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease.
4. Patients have an ICD implanted for secondary prevention.
5. Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression.
6. Patients with any illness expected to result in death within 18 months of enrollment.
7. Patients with white blood cell dyscrasia or cancers.
8. Patients with end-stage renal disease (ESRD) on hemodialysis or peritoneal dialysis
9. Current illicit drug use.
10. Inability to give informed consent.

Study Design

Enrollment

450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: ICD group

Adult patients with newly implanted ICD devices for primary prevention will be enrolled. At baseline, 3-, 6-, 9-, and 12-month followup visit, the medial information and blood samples will be collected.

Interventions

Implantable cardioverter-defibrillator (ICD)

Patients with newly implanted implantable cardioverter-defibrillators (ICDs) for primary prevention will be enrolled.

Primary outcome measure

  • The levels of sodium channel splicing variants measured by gene expression that are related to arrhythmic events, change every 3 months from baseline to one 1 year after ICD therapy. [ Time Frame: baseline, 3-month, 6-month, 9-month, and 12-month after ICD therapy ]

Central Contacts and Locations

Central contacts

Lori-Ann DeSimone, RN,BSN

(401) 793-5554

Michael Orlov, MD

401-793-4107

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Lori-Ann Desimone, RN, BSN

401-793-5554

Michael Orlov, MD

401-793-4107

Principal Investigator:

Michael Orlov, MD

More Information

Sponsor

Rhode Island Hospital

Last update posted

Apr 12, 2017

Last verified

Apr, 2017

Keywords

  • sudden cardiac death, sodium channel splicing variant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2017-04-12.