NCT01989299已完成不适用
Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction (VIP-HF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 5
- 主要终点
- The incidence of sustained ventricular tachyarrhythmias.
研究概览
简要总结
Heart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac death is suggested as the most common cause of death in HFPEF patients, although data is sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter Defibrillator (ICD) may be an option in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria:
- •Age >18 years
- •Written informed consent
- •HF with moderate to severe symptoms NYHA II or III
- •Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months
- •Sinus rhythm or AF
- •Echocardiographic criteria:
- •Left atrial size (volume ≥34 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s).
- •Biomarker criteria:
- •BNP >100ng/L or NT-pro-BNP>400ng/L if sinus rhythm
- •BNP >300ng/L or NT-pro-BNP>1200ng/L if atrial fibrillation
排除标准
- •Patients unwilling or unable to sign informed consent
- •Patients with a pacemaker or ICD
- •Indication for ICD therapy according to the ESC guidelines
- •Life expectancy of less than one year
- •Significant coronary artery disease or myocardial infarction < 3 months
- •Complex congenital heart disease
结局指标
主要结局
The incidence of sustained ventricular tachyarrhythmias.
时间窗: 2 years after ILR implantation
To study the incidence of ventricular tachyarrhythmias in patients with HFPEF at high-risk for arrhythmic mortality.
次要结局
- The incidence of atrial fibrillation (AF) in patients without baseline or history of AF(2 years after ILR implantation)
- Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias(2 years after ILR implantation)
- Biomarkers (including echocardiography, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality(2 years after ILR implantation)
- The rate of progression of AF in patients without baseline or history of AF(2 years after ILR implantation)
- The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death(2 years after ILR implantation)
- The incidence of non-sustained ventricular tachyarrhythmias(2 years after ILR implantation)
- Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) for incident AF, and progression of AF in patients without baseline or history of AF(2 years after ILR)
- Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias(2 years after ILR implantation)
研究者
M. Rienstra
dr.
University Medical Center Groningen
研究点 (5)
Loading locations...
相似试验
招募中
不适用
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection FractionHeart Failure With Preserved Ejection Fraction (HFpEF)NCT05792059National Medical Research Center for Therapy and Preventive Medicine80
进行中（未招募）
不适用
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure PatientsHeart FailureAtrial FibrillationNCT04818645University of Rochester477
尚未招募
不适用
Novel Wearable Device for Heart Failure ManagementHeart FailureNCT05642650China-Japan Friendship Hospital108
已完成
不适用
Polypill Strategy for Heart Failure With Reduced Ejection FractionHeart FailureNCT04633005University of Texas Southwestern Medical Center212
招募中
不适用
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEFMicrovascular Coronary Artery DiseaseHeart Failure With Reduced Ejection FractionNCT06316661Istituto Auxologico Italiano60