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

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%.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiac Resynchronisation Therapy
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy

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%.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Pipin Kojodjojo, MD PHD; Phone Number: 67795555

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
    • Contact: Pipin Kojodjojo, MD PHD; Phone Number: 67795555
    • Principal Investigator: Swee Chong Seow, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Singaporean patients with broad QRS complexes, EF <40%, heart failure, requiring CRT

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart Failure receiving CRT; Heart failure patients with QRS > 120ms receiving CRT	Device: Cardiac Resynchronization Therapy; Cardiac resynchronization therapy with or without ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic response to CRT	A subject is considered an echocardiographic responder to CRT if there is: reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of >/= 15% OR; an increase in the LVEF of >/= 10% during follow-up echocardiography at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroendocrine response to CRT	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	6 months
Clinical response to CRT	A subject is considered a positive clinical responder to CRT if: NYHA class has improved by at least 1 class OR; 6 minutes walking test has increased by at least 10%	6 months
Hospitalization For Cardiovascular events	Hospitalisation for acute coronary syndrome, heart failure, arrhythmias, ICD shocks or any unplanned admissions for any cardiac interventions or surgery	8 years
Mortality	Mortality	8 years

Collaborators and Investigators

• Sponsor: National University Heart Centre, Singapore
• Investigators: Principal Investigator: Swee Chong Seow, MD, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2030
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2016/00608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO