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Prospective Evaluation of Asians With CRT for Heart Failure (PEACH)

N

National University Heart Centre, Singapore

Status

Enrolling

Conditions

Cardiac Resynchronisation Therapy
Heart Failure

Treatments

Device: Cardiac Resynchronization Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT02814942
2016/00608

Details and patient eligibility

About

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%.

Full 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%.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Heart Failure receiving CRT
Description:
Heart failure patients with QRS \> 120ms receiving CRT
Treatment:
Device: Cardiac Resynchronization Therapy

Trial contacts and locations

1

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Central trial contact

Pipin Kojodjojo, MD PHD

Data sourced from clinicaltrials.gov

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