Ventricular tachyarrhythmia detection by Implantable Loop Recording in Patients with Heart Failure and Preserved Ejection Fractio

Phase 2

Completed

• Conditions: Diastolic heart failure; heart failure with preserved ejection fraction; 10019280

• Registration Number: NL-OMON47257
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Clinical criteria:
1. Age >18 years
2. Written informed consent
3. HF with moderate to severe symptoms NYHA II or III
4. Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months
5. Sinus rhythm or AF with adequate rate control (exercise test: maximum heart rate <160 bpm) ;Echocardiographic criteria:
1. LVEF >40%
2. Left atrial size (volume *34 mL/m2 or LA parasternal diameter *45 or left ventricular hypertrophy (septal thickness or posterior wall thickness *11 mm) of left ventricular diastolic dysfunction (E/e* *13 or mean e* septal and lateral wall <9 cm/s).;Biomarker criteria:
1. BNP >75ng/L or NT-pro-BNP>300ng/L if sinus rhythm
2. BNP >225ng/L or NT-pro-BNP>900ng/L if atrial fibrillation

Exclusion Criteria

1. Patients unwilling or unable to sign informed consent
2. Patients with a pacemaker or ICD
3. Indication for ICD therapy according to the European Society of Cardiology (ESC) guidelines
4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction < 3 months
6. Complex congenital heart disease
7. Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective (efficacy) is to assess the incidence of sustained<br /><br>ventricular tachyarrhythmias.</p><br>