Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00051

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Takeda Chemical Industries, LTD

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

Leata Chan

ii Address

iii Phone

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

iv Email

leata@chuk.edu.hk

v Affiliation

vi Country

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

i Name

Prof. John E. Sanderson

ii Address

iii Phone

Professor of Cardiology, Keele University Medical School

iv Email

ohn.Sanderson@uhns.nhs.uk

v Affiliation

vi Country

9 Official Scientific Title of the Study

The effect of angiotensin receptor blockade alone or in combination with spironolactone on the process of ventricular remodeling in chronic heart failure.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2001-07-03

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

Drug

Please specify

ii Description/ name of Intervention/article

Heart Failure Patients

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

one year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Candesartan + Spirolactone verus Candesartan + Placebo

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

Inclusion criteria *Typical features of congestive heart failure. *LVEF < 40%. Exclusion criteria *Patients with renal failure, serum creatinine > 200 mmol/ltr. *Other major serious medical conditions such as malignancy, liver failure, uncontrolled diabetes. Gender and age will be balanced in the two randomized groups.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

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

2001-10-08

21 Target Sample Size

50

22 Recruitment Status

Complete

23 Primary Outcome

We sought to determine the beneficial effect of candesartan alone or in combination with spironolactone on left ventricular remodelling

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

2009-12-28

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

None

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Trial History Detail on 2005-09-09