Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00381

2 Trial Registration Date

2013-11-06

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Division of Cardiology, Department of Medicine and Therapeutics

5 Primary Sponsor

NO

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Xue-Ting WANG

ii Address

Heart center 10/F,Department of medicine and Therapeutics, Clinical Science Building Prince of Wales Hospital, Shatin,Hong Kong.

iii Phone

26321752

iv Email

xueting@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Prof.Cheuk-Man YU

ii Address

9/F, Department of medicine and Therapeutics, Clinical Science Building Prince of Wales Hospital, Shatin,Hong Kong.

iii Phone

26323594

iv Email

cmyu@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

Asian Prospective Registry for Valvular Heart Disease

10 Public Title

Asian Prospective Registry for Valvular Heart Disease

i Public Title in Chinese 研究名稱

亞洲心臟瓣膜病前瞻性登記冊

11 Short Title (Optional)

Asian Prospective Registry for Valvular Heart Disease

12 Countries of Recruitment

Hong Kong CHINA

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-10-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Valvular Heart Disease

15 Intervention

i Types of intervention

Other

Please specify

N/A

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

a)Patients with significant MR or AS (≥mild)
b)Patients with organic MR or AS
c)Patients able to undergo a comprehensive echocardiographic evaluation
d)The patient or the guardian gives written informed consent before participating the study.
e) The patient is willing to give full information on his/her medical history, including the drugs

ii Exclusion Criteria

a)Patient with functional (for example, ischemic MR) MR
b)Patient with concomitant valvular heart disease other than MR or AS
c)Patient with other concomitant congenital heart disease

iii Age Minimum

N/A

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-11-20

21 Target Sample Size

300

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Composite endpoint of admission for heart failure, worsening of functional capacity with NYHA functional classification and death.

24 Secondary Outcome

Functioncal capacity with NYHA functional classification
All-cause death;
(Sudden) Cardiac death;
Hospitalization for worsening heart failure;
Stroke;
Significant arrhythmia that needs admission.
Surgery for worsening valvular heart disease.
Echocardiographic parameters, such as LV dimension, ejection fraction, pulmonary artery systolic pressure

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-28

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-13003773

28 Date of Registration in Primary Registry

2013-11-11

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2013-11-13