Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00459

2 Trial Registration Date

2015-06-19

i Registration Status

Prospective

3 Secondary IDs

EC.2015.68

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Health and Medical Research Fund

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Fang Fang

ii Address

HEART CENTER, Clinical Science Building, Division of Cardiology, Prince of Wales Hospital

iii Phone

37636050

iv Email

fang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Fang Fang

ii Address

HEART CENTER, Clinical Science Building, Division of Cardiology, Prince of Wales Hospital

iii Phone

37636050

iv Email

fang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

The Scoring System with Multimodality Echocardiography to Predict Event for
Chronic Stable Heart Failure Patients with Normal Ejection Fraction

10 Public Title

The Scoring System with Multimodality Echocardiography to Predict Event for
Chronic Stable Heart Failure Patients with Normal Ejection Fraction

i Public Title in Chinese 研究名稱

多種形式超聲心動圖預測射血分數正常的慢性穩定心力衰竭事件

11 Short Title (Optional)

Echocardiographic scoring and heart failure with normal ejection fraction

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?

2015-03-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart failure with normal ejection fraction

15 Intervention

i Types of intervention

Other

Please specify

Observational stduy

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

36 moths

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

HFNEF patients will be enrolled from in-patient and out-patient clinic based at the Prince of Wales Hospital, Shatin (Diagnosis based on ESC guidelines).
Inclusion Criteria
(1) with clinical symptoms or signs of HF;
(2) with evidence of normal left ventricular systolic function (ejection fraction ≥50%).
(3) with evidence of abnormal left ventricular diastolic function.
(4) age >18 years

ii Exclusion Criteria

(1) Left ventricular ejection fraction <50%.
(2) Expected life expectancy <6months.
(3) Refuse to participate in this study.
(4) Acute coronary syndromes, congenital valvular heart disease or infiltrative, restrictive or hypertrophic cardiomyopathy
(5) Very poor acoustic window for echocardiographic examination

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Double-blind

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

2015-07-05

21 Target Sample Size

300

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Cardiovascular mortality and / or heart failure re-hospitalizations

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

2015-07-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-07-02