Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification

Heart Failure With Reduced Ejection Fraction Clinical Trial

— PERFECT  

Official title:

Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539898
• Other study ID #: ONRS_01
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2017
• Est. completion date: December 29, 2024

Study information

• Verified date: January 2023
• Source: Astrakhan Federal Centre For Cardiac Surgery
• Contact: Nikolay N Ilov, MD
• Email: nikolay.ilov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.

Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 29, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• LV EF = 35% inspite of optimal drug therapy of heart failure (3 months and longer)

• NYHA II-IV

• favorable prediction of survival for 1 year or more

Exclusion Criteria:

• secondary SCD prevention

• indications for open heart surgery

• hypertrophic cardiomyopathy

• arrhythmogenic right ventricular dysplasia

• genetic channelopathies

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• ICD implantation
All included in the study will undergo ICD implantation for primary prevention of SCD

Locations

Country	Name	City	State
Russian Federation	Federal Center for Cardiovascular Surgery	Astrakhan	Astrakhan Region

Sponsors (1)

Lead Sponsor	Collaborator
Astrakhan Federal Centre For Cardiac Surgery

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Ilov NN, Palnikova OV, Stompel DR, Nechepurenko capital A, CyrillicA. Clinical Predictors of Occurrence of Ventricular Tachyarrhythmias in Patients with Reduced Left Ventricle Ejection Fraction. Results of Single-Center Prospective Study. Kardiologiia. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of VT primary occurrence	A stable paroxysm of VT (lasting = 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.	24 months
Secondary	Rate of Cardiac Mortality	Registration of cardiac death	24 months
Secondary	Number of Participants with CRT Response	Registration of CRT Response evaluated by transthoracic echocardiography	24 months