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Trial History Detail on 2011-08-19

CUHK_CCT00138

2010-06-04

Retrospective

Nil

RGC funding for the study

RGC funding

Nil

Cheuk Man Yu

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

2632 1752

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

Nil

Cheuk Man Yu

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

2632 1752

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

Nil

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

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

Nil

Hong Kong

Yes

2006-02-07

Chronic obstructive pulmonary disease (COPD)

Procedure

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

5 years

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).

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%.

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

> 18 years of age

Patient > 18 years of age

Both Male and Female

Observational

Non-randomized

Active

Open label

Parallel

2006-03-27

150 patien

Complete

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.

Nil

No

2014-01-29

ChiCTR-TRC-10000909

2010-06-25


Yes

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