Prospective Evaluation of Asians With CRT for Heart Failure | NCT02814942

Studies
Prospective Evaluation of Asians With CRT for Heart Failure

NCT02814942

Sponsor

National University Heart Centre, Singapore

Status

Recruiting

Last Update Posted

Mar 9, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Heart Failure
Cardiac Resynchronisation Therapy

Interventions

Cardiac Resynchronization Therapy

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 27, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2021

Last Update Posted Date

Mar 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pipin Kojodjojo, Consultant Cardiac Electrophysiologist, National University Heart Centre, SingaporePrincipal Investigator

Lead Sponsor

National University Heart Centre, SingaporeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart Failure receiving CRT		Heart failure patients with QRS > 120ms receiving CRT	Device: Cardiac Resynchronization Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy	Device	Cardiac resynchronization therapy with or without ICD	Heart Failure receiving CRT

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pipin Kojodjojo, MD PHD	Contact	67795555

Overall Officials

Name	Affiliation	Role
Swee Chong Seow, MD	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore			Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058406	Cardiac Resynchronization Therapy

Ancestor Terms

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided