Prospective Evaluation of Asians With CRT for Heart Failure

Heart Failure Clinical Trial

— PEACH  

Official title:

Prospective Evaluation of Asians With CRT for Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02814942
• Other study ID #: 2016/00608
• Status: Recruiting
• Start date: January 2011
• Est. completion date: December 2030

Study information

• Verified date: March 2021
• Source: National University Heart Centre, Singapore
• Contact: Pipin Kojodjojo, MD PHD
• Phone: 67795555
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronisation Therapy
• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy
Cardiac resynchronization therapy with or without ICD

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Heart Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mortality	Mortality	8 years