Prospective Evaluation of Asians With CRT for Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Resynchronization Therapy.
- Who it may be relevant to
- Registry conditions: Heart Failure, Cardiac Resynchronisation Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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%.
Interventions
- Device Cardiac Resynchronization Therapy
Cardiac resynchronization therapy with or without ICD
Primary outcome measures
- Echocardiographic response to CRT [Time frame: 6 months]
Secondary outcome measures (4)
- Neuroendocrine response to CRT [Time frame: 6 months]
- Clinical response to CRT [Time frame: 6 months]
- Hospitalization For Cardiovascular events [Time frame: 8 years]
- Mortality [Time frame: 8 years]
Eligibility criteria
Inclusion criteria
- Broad QRS (>120 ms)
- EF < 40%
- Symptomatic heart failure
- Not on optimal medical therapy
Exclusion criteria
- Pregnant
- < 18 years of age
- Infection
- Unable to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Singapore · 1 center
- National University Hospital — Singapore
Identifiers
NCT: NCT02814942 · 2016/00608