PEACH: Prospective Evaluation of Asians With CRT for Heart Failure

• Sponsor: National University Heart Centre, Singapore (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02814942
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 239
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Cardiac Resynchronisation Therapy	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Evaluation of Asians With CRT for Heart Failure
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2030
• Anticipated Study Completion Date: Dec 1, 2030

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Echocardiographic response to CRT [6 months]

   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

Secondary Outcome Measures

1. Neuroendocrine response to CRT [6 months]

   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

2. Clinical response to CRT [6 months]

   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%

3. Hospitalization For Cardiovascular events [8 years]

   Hospitalisation for acute coronary syndrome, heart failure, arrhythmias, ICD shocks or any unplanned admissions for any cardiac interventions or surgery

4. Mortality [8 years]

   Mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University Hospital	Singapore		Singapore

Sponsors and Collaborators

• National University Heart Centre, Singapore

Investigators

• Principal Investigator: Swee Chong Seow, MD, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pipin Kojodjojo, Consultant Cardiac Electrophysiologist, National University Heart Centre, Singapore
• ClinicalTrials.gov Identifier: NCT02814942
• Other Study ID Numbers: 2016/00608
• First Posted: Jun 28, 2016
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Mar 9, 2021