Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00281

2 Trial Registration Date

2011-10-11

i Registration Status

Retrospective

3 Secondary IDs

None

4 Source(s) of Funding

General Research Fund (GRF)

5 Primary Sponsor

General Research Fund (GRF)

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Skiva Chan

ii Address

Dept of Medicine & Therapeutics, CUHK

iii Phone

26463200

iv Email

skivachan@cuhk.edu.hk

v Affiliation

PWH

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Cheuk-Man YU

ii Address

Dept of Medicine & Therapeutics, CUHK

iii Phone

26323594

iv Email

cmyu@cuhk.edu.hk

v Affiliation

PWH

vi Country

9 Official Scientific Title of the Study

Establishment of a Comprehensive Model that Predicts Favorable Response after Cardiac Resynchronization Therapy

10 Public Title

Establishment of a Comprehensive Model that Predicts Favorable Response after Cardiac Resynchronization Therapy

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-01-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart Failure

15 Intervention

i Types of intervention

Other

Please specify

None

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with HF due to systolic dysfunction who are suitable candidates for CRT according to the current ACC/AHA/ESC guidelines will be enrolled, namely, patients with NYHA class III or IV, ejection fraction <35%, prolonged QRS duration of >120ms, and refractory to optimal medical therapy including neurohormonal blockers.2 Patients with atrial fibrillation are accepted for CRT from current guideline and hence will be induced. However, measures will be taken to ensure a high percentage of biventricular pacing (e.g. aggressive beta-blockers, digoxin etc).

ii Exclusion Criteria

1.HF with LV ejection fraction > and = 35%
2.Any major illnesses with life expectancy <6months, e.g., terminal malignancy
3.Patients unwilling to participate into the study or refuse or deemed unsuitable for CRT

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-02-16

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

To develop and validate a comprehensive clinical model with a scoring system that will increase the response rate of CRT

24 Secondary Outcome

To improve the overall response rate of CRT from primarily a clinical perspective to secondarily a cardiac functional perspective

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-11-29

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-11001650

28 Date of Registration in Primary Registry

2011-11-03

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2011-12-01