Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00403

2 Trial Registration Date

2014-04-08

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.618

4 Source(s) of Funding

Pending

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

SHANG, Qing

ii Address

Department of Medicine & Therapeutics, CUHK

iii Phone

2635 2217

iv Email

qingshang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

HONG KONG S.A.R., CHINA

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

i Name

SHANG, Qing

ii Address

Department of Medicine & Therapeutics, CUHK

iii Phone

2635 2217

iv Email

qingshang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

HONG KONG S.A.R., CHINA

9 Official Scientific Title of the Study

Reactive myocardial fibrosis related mechanical dyssynchrony in patients with hypertension – An early marker of myocardial involvement?

10 Public Title

Reactive myocardial fibrosis related mechanical dyssynchrony in patients with hypertension – An early marker of myocardial involvement?

i Public Title in Chinese 研究名稱

高血壓病人反應性心肌纖維化相關的心肌機械性不同步 – 心肌早期損傷的標誌？

11 Short Title (Optional)

Reactive myocardial fibrois & mechanical dyssynchorny

12 Countries of Recruitment

Hong Kong Special Administrative Region, People's Republic of China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-21

iii Full Name of IRB/IEC

Hong Kong East Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2013.618

14 Medical Condition Being Studied

Hypertension

15 Intervention

i Types of intervention

Other

Please specify

None

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with hypertension which is defined as systolic blood pressure (SBP) ≥140mmHg or diastolic blood pressure (DBP) ≥90mmHg or the use of antihypertensive agents

ii Exclusion Criteria

Pregnancy, hypothyroidism, clinically significant renal disease (serum creatinine level ≥ 270ìmol/l), secondary hypertension and diabetes mellitus. Those with LV ejection fraction <50% or myocarditis, evidence of clinical coronary artery or pericardial disease, coronary revascularization, bundle-branch block, second-degree or higher atrioventricular block, atrial fibrillation, or greater than mild aortic or mitral valve diseases.

iii Age Minimum

18 years

iv Age Maximum

N/A

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

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-01-05

21 Target Sample Size

400

22 Recruitment Status

Unknown

23 Primary Outcome

Changes of fibrosis and dyssynchorny after 2 years

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

2016-11-15

27 Primary Registry and Trial Identifying Number

ChiCTR-TCS-14004477

28 Date of Registration in Primary Registry

2014-04-10

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Trial Detail