Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00282

2 Trial Registration Date

2011-10-11

i Registration Status

Retrospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Collaborative Research Fund (CRF)

5 Primary Sponsor

Collaborative Research Fund (CRF)

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

Schematic Identification of Predictors of Treatment Non-Responders in Patients with Systolic Heart Failure

10 Public Title

Schematic Identification of Predictors of Treatment Non-Responders in Patients with Systolic Heart Failure

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?

2010-11-02

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

Stable HF patients with left ventricular (LV) ejection fraction <50%.
Patients who are candidates for device therapy (e.g. CRT or ICD) will be enrolled into the study 6 months after having received the device therapy.

ii Exclusion Criteria

1.HF with LV ejection fraction > and = 50%, or so-called “diastolic” HF
2.Any major illnesses with life expectancy <6months, e.g., terminal malignancy
3.Patients unwilling to participate in the study.

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

2011-04-30

21 Target Sample Size

700

22 Recruitment Status

Recruiting

23 Primary Outcome

Develop useful predictive markers of non-responders to heart failure treatment

24 Secondary Outcome

Develop an "Assessment Model" that predict heart failure response with high accuracy

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-11001651

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