Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00035

2 Trial Registration Date

2005-09-07

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Sanofi-Synthelabo H.K. 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

Skiva Chan

ii Address

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

iii Phone

2646-3200

iv Email

v Affiliation

vi Country

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

i Name

Prof. John E. Sanderson

ii Address

iii Phone

iv Email

j.e.sanderson@bham.ac.uk

v Affiliation

Professor of Clinical Cardiology, University of Birmingham

vi Country

9 Official Scientific Title of the Study

Treatment of Diastolic Heart Failure: The Role of Blockade of the Renin-Angiotensin System. A Comparison of Diuretics with an Angiotensin Converting Enzyme Inhibitor, Angiotensin Receptor Blockade or Diuretics Alone

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?

1998-05-01

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

Diastolic Failure Patients

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Ramipril + Diuretics vs. Irbesartan +Diuretics vs. Diuretics alone

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:1. Signed informed consent 2. Age >18 yrs 3. history of heart failure for 2 months prio to screening 4. NYHA Functional Class II-IV 5. LV EF >45% by ECHO or a radionucleotide technique 6. Therapy with diuretics with stable dose >14 days prior to screening.

ii Exclusion Criteria

Exclusion: 1. NHYA class I 2. Inability to answer the QOL questionnaire 3. Myocardial infarction within 3 months, 4. unstable angina within 1 month 5. Significant cardiac valvular heart disease 6. Hypotension SBP <90 mmHg 7. uncontrolled hypertension(DBP>105 ors SBP> 200 mmHg) 8. uncontrolled serious cardiac arrhythmias associated with a ventricular rate >100 bpm at study entry 9. concurrent therapy with CCB, Betablocker, ACEI, AII or positive inotropic agents other than digoxin for control of AF

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Uncontrolled

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

1999-07-13

21 Target Sample Size

450

22 Recruitment Status

Complete

23 Primary Outcome

1. Number of hospital admissions for heart failure or mortality 2. Quality of life assessed by the Minnesota Quality of life Questionnaire 3. In ambulatory patients the exercise duration assesssed by 6 min corridor walk test

24 Secondary Outcome

The incidence of side-effects, effect on levels of natriuretic peptides, effect on doppler-echocardiographic derived measurements of left ventricular diastolic function.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-25

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

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Trial History Detail on 2009-11-19