Prospective Evaluation of Asians With CRT for Heart Failure

NCT ID: NCT02814942

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2030-12-31

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%.

Conditions

Heart Failure; Cardiac Resynchronisation Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure receiving CRT

Heart failure patients with QRS \> 120ms receiving CRT

Cardiac Resynchronization Therapy

Intervention Type: DEVICE

Cardiac resynchronization therapy with or without ICD

Interventions

Cardiac Resynchronization Therapy

Cardiac resynchronization therapy with or without ICD

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Heart Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Pipin Kojodjojo

Consultant Cardiac Electrophysiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Swee Chong Seow, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Pipin Kojodjojo, MD PHD

Role: CONTACT

67795555

Facility Contacts

Pipin Kojodjojo, MD PHD

Role: primary

67795555

Other Identifiers

2016/00608

Identifier Type: -

Identifier Source: org_study_id