Clinical trial NCT02814942: Prospective Evaluation of Asians With CRT for Heart Failure
Official title: Prospective Evaluation of Asians With CRT for Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Cardiac Resynchronisation Therapy
Lead sponsor: National University Heart Centre, Singapore
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singaporean patients with broad QRS complexes, EF \<40%, heart failure, requiring CRT

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%.

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

Primary outcomes:
measure: Echocardiographic response to CRT
timeFrame: 6 months
Secondary outcomes:
measure: Neuroendocrine response to CRT
timeFrame: 6 months
measure: Clinical response to CRT
timeFrame: 6 months
measure: Hospitalization For Cardiovascular events
timeFrame: 8 years
measure: Mortality
timeFrame: 8 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Swee Chong Seow, MD
role: PRINCIPAL_INVESTIGATOR
References: