Prospective Evaluation of Asians With CRT for Heart Failure
- Conditions
- Heart FailureCardiac Resynchronisation Therapy
- Interventions
- Device: Cardiac Resynchronization Therapy
- Registration Number
- NCT02814942
- Lead Sponsor
- National University Heart Centre, Singapore
- Brief Summary
Aim:To determine the baseline characteristics of heart failure patients in Singapore undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of response to CRT.
Methodology:Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure.
The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the LVEF of \>/= 10%.
- Detailed Description
Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, comorbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure. The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the LVEF of \>/= 10%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Broad QRS (>120 ms)
- EF < 40%
- Symptomatic heart failure
- Not on optimal medical therapy
- Pregnant
- < 18 years of age
- Infection
- Unable to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart Failure receiving CRT Cardiac Resynchronization Therapy Heart failure patients with QRS \> 120ms receiving CRT
- Primary Outcome Measures
Name Time Method Echocardiographic response to CRT 6 months A subject is considered an echocardiographic responder to CRT if there is:
1. reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% OR
2. an increase in the LVEF of \>/= 10% during follow-up echocardiography at 6 months
- Secondary Outcome Measures
Name Time Method Hospitalization For Cardiovascular events 8 years Hospitalisation for acute coronary syndrome, heart failure, arrhythmias, ICD shocks or any unplanned admissions for any cardiac interventions or surgery
Mortality 8 years Mortality
Neuroendocrine response to CRT 6 months A subject is considered to have a neuro-endocrine response to CRT if BNP levels at 6 months post CRT implant has fallen more than 30% from baseline
Clinical response to CRT 6 months A subject is considered a positive clinical responder to CRT if:
1. NYHA class has improved by at least 1 class OR
2. 6 minutes walking test has increased by at least 10%
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore