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

Ventricular tachyarrhythmia detection by Implantable Loop Recording in Patients with Heart Failure and Preserved Ejection Fraction - VIP-HF Registry

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47257

Enrollment

250

Registered

2014-06-16

Start date

2014-12-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic heart failure

Interventions

ICD implantation.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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 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

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

Design outcomes

Primary

Measure	Time frame
The primary objective (efficacy) is to assess the incidence of sustained ventricular tachyarrhythmias.	—

Secondary

Measure	Time frame
1. To assess the incidence of all cause mortality, cardiovascular mortality, and sudden cardiac death 2. To assess the incidence of ICD-related complications 3. To assess the incidence of non-sustained tachyarrhythmias or slow ventricular arrhythmias 4. To assess the incidence and burden of AF 5. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for adequate ICD therapies 6. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for inadequate ICD therapies 7. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for development of atrial or ventricular arrhythmias 8. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations and mortality 9. To assess the relation between cardiac amyloid deposition and other biomarkers (including ECG, 6 minute walk test, Holter, echocardiography, CMR and blood biomarkers) and incidence of sustained ventricular tachyarrhythmias, incidence of atrial fibrillation, and development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality	—

Measure

Time frame

1. To assess the incidence of all cause mortality, cardiovascular mortality, and sudden cardiac death 2. To assess the incidence of ICD-related complications 3. To assess the incidence of non-sustained tachyarrhythmias or slow ventricular arrhythmias 4. To assess the incidence and burden of AF 5. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for adequate ICD therapies 6. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for inadequate ICD therapies 7. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for development of atrial or ventricular arrhythmias 8. To assess biomarkers (including echocardiography, 6 minute walk test, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations and mortality 9. To assess the relation between cardiac amyloid deposition and other biomarkers (including ECG, 6 minute walk test, Holter, echocardiography, CMR and blood biomarkers) and incidence of sustained ventricular tachyarrhythmias, incidence of atrial fibrillation, and development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)