Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00036

2 Trial Registration Date

2005-09-07

i Registration Status

Retrospective

3 Secondary IDs

None

4 Source(s) of Funding

CUHK

5 Primary Sponsor

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Prof. Yu Cheuk Man

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

2632-3594

iv Email

cmyu@cuhk.edu.hk

v Affiliation

PWH

vi Country

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

i Name

Prof. Yu Cheuk Man

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

2632-3594

iv Email

cmyu@cuhk.edu.hk

v Affiliation

PWH

vi Country

9 Official Scientific Title of the Study

Biventricular Pacing in Patients with Congestive Heart Failure

10 Public Title

Biventricular Pacing in Patients with Congestive 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?

2002-02-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Biventricular pacing for 3 months post implant, then switch to sensing mode for 4 weeks and back to biventicular pacing again.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8 months

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

- symptomcatic heart failure
- dilated LV
-EF < or = 35%

ii Exclusion Criteria

- < 18 years of age
- patient has unstable angina
- MI within 3 months
- Coronary revascularization within 3 months
- Restrictive cardiomyopathy
- Acute myocarditis

iii Age Minimum

> or = 18 years of age

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2002-02-05

21 Target Sample Size

200

22 Recruitment Status

Complete

23 Primary Outcome

Evaluate ECHO, Minnesota Questionnaire, Treadmill, 6 minutes hall walk at 1 week, 4 week and 3 month post implant when patient is on biventricular pacing. Repeat assessment at 1 week and 4 week after switching to sensing mode. Repeat assessment again 3 month after switch back to biventricular pacing.

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TNRC-09000633

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2011-02-08