Prospective Evaluation of Asians With CRT for Heart Failure

NCT02814942 | Recruiting

• 1 other identifier: 2016/00608
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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%.

Conditions

Heart Failure; Cardiac Resynchronisation Therapy

Outcome Measures

Primary Outcomes (1)

• Echocardiographic response to CRT

  A subject is considered an echocardiographic responder to CRT if there is: 1. reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% OR 2. an increase in the LVEF of \>/= 10% during follow-up echocardiography at 6 months

  6 months

Secondary Outcomes (4)

• Neuroendocrine response to CRT

  6 months

• Clinical response to CRT

  6 months

• Hospitalization For Cardiovascular events

  8 years

• Mortality

  8 years

Study Arms (1)

Heart Failure receiving CRT

Heart failure patients with QRS \> 120ms receiving CRT

Device: Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization Therapy DEVICE

Cardiac resynchronization therapy with or without ICD

Heart Failure receiving CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Broad QRS (\>120 ms)
• EF \< 40%
• Symptomatic heart failure
• Not on optimal medical therapy

You may not qualify if:

• Pregnant
• \< 18 years of age
• Infection
• Unable to consent

Sponsors & Collaborators

• National University Heart Centre, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum saved for biomarking

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Swee Chong Seow, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pipin Kojodjojo, MD PHD

CONTACT

67795555

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiac Electrophysiologist

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 28, 2016
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)