Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00138

2 Trial Registration Date

2010-06-04

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

RGC funding for the study

5 Primary Sponsor

RGC funding

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Cheuk Man Yu

ii Address

Rm. 12A28, 12/F, Main Building, PWH

iii Phone

2632 1752

iv Email

cmyu@cuhk.edu.hk / poonsps@yahoo.com.hk

v Affiliation

Nil

vi Country

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

i Name

Cheuk Man Yu

ii Address

Rm. 12A28, 12/F, Main Building, PWH

iii Phone

2632 1752

iv Email

cmyu@cuhk.edu.hk / poonsp@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function

10 Public Title

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function

i Public Title in Chinese 研究名稱

利用組織多普勒超聲波, 對早期的右心室功能不全, 以及其對左心室功能的影響, 進行一系列的超聲波評估

11 Short Title (Optional)

Nil

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?

2006-02-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Chronic obstructive pulmonary disease (COPD)

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Serial Echocardiographic examine the effect of Chronic Obstructive Pulmonary Disease of Early Right Ventricular Dysfunction

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

5 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The goal of the proposed research project is to examine the effect of chronic obstructive pulmonary disease (COPD) on early occurrence of right ventricular [RV] dysfunction in both systole and diastole independent of development of hypertension, and its impact on left ventricular [LV] function. This can be achieved by the use of a sensitive echocardiographic tools, namely tissue Doppler imaging (TDI) and 3-dimensional echocardiography (3DE).

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

1). Patients diagnosed with COPD who are stable (without history of acute exacerbation of COPD in the past 3 months before enrolment), and,
2). Objective evidence of abnormal and obstructive lung function by spirometry, with FEV1 between 30-80% of normal age-predicted value and FEV1/FVC ratio <70%.

ii Exclusion Criteria

1). COPD with history of hospitalization due to acute exacerbation within the past 3 months
2). COPD who are dependent on assisted ventilation of any kind that may affect cardiac function
3). Patients who have other interstitial lung disease, e.g. pneumoconiosis, bronchiectasis, alveolar fibrosis, etc
4). Patients with other active lung pathologies, such as primary or secondary lung malignancies, pneumonia, active tuberculosis, pleural effusion, etc
5). Patients with primary pulmonary hypertension
6). Patients with secondary pulmonary hypertension other than due to COPD, such as thromboembolism
7). Patients who known structural heart disease, such as coronary heart disease, left ventricular hypertrophy, significant valvular heart disease, cardiomyopathies, etc
8). Patients with active cardiac arrhythmias such as atrial fibrillation
9). Patients with active systemic illness or end-organ disease that may affect cardiac or pulmonary function, such as renal or liver failure
10). Patients with disease with expected life expectancy <1 year, such as malignancies
11). Patients who refuse to participate the study

iii Age Minimum

> 18 years of age

iv Age Maximum

Patient > 18 years of age

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

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

2006-03-27

21 Target Sample Size

150 patien

22 Recruitment Status

Complete

23 Primary Outcome

Patients enrolled into the study will perform baseline assessment that include spirometry with DLCO, ECG, echo (with TDI and 3DE) examination, 6-Minute hall walk test, quality of life by St. Georges Respiratory Questionnaire, and blood test for neurohormones (B-type natriuretic peptides [BNP]), N-terminal Pro-BNP, epinephrine and norepinephrine). The investigation data collected from the Cross-sectional study will also be used as the baseline tests for the Prospective study. Patients will then be followed by regularly by the respiratory physicians in the outpatient specialist clinic of the hospital at regular intervals for a total duration of 12 months. The occurrence of major events including hospitalization of acute COPD will be monitored. During follow-up, investigations will be performed to examine for the changes in cardiac and lung functions, clinical status, quality of life and neurohormonal levels. As subjects enrolled into the study are stable COPD patients, change of regular medications are discouraged unless clinically indicated.

24 Secondary Outcome

Nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-01-29

27 Primary Registry and Trial Identifying Number

ChiCTR-ONRC-10000909

28 Date of Registration in Primary Registry

2010-06-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-09-11