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

PREDICT-CRT - Predict Cardiac Resynchronization Therapy Response by a Multi-parametric Model

10 Public Title

PREDICT-CRT - Predict Cardiac Resynchronization Therapy Response by a Multi-parametric Model

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. Patients with atrial fibrillation are accepted for CRT from current guideline and hence will be included. 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 > 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

420

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 2012-10-25