- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035148
CPET in Evaluation of PH in COPD Patients
Cardiopulmonary Exercise Test in Evaluation of Pulmonary Hypertension in COPD Patients
- To evaluate the entire course of exercise during CPET in COPD patients.
- To study whether CPET, PFTs and arterial blood gases could discriminate between COPD patients with and without PH.
- To study whether the existence of pulmonary hypertension in COPD is related to characteristic findings in gas exchange and circulatory parameters during cardiopulmonary exercise testing (CPET).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
(COPD) is a common cause of pre-capillary pulmonary hypertension (PH). Pulmonary hypertension (PHT) is a common complication of COPD and is determinant for the prognosis of COPD.
PHT is defined as A mean PAP of ≥ 25 mmHg measured by right heart catheterization at rest.
Exercise tolerance in patients with COPD is reduced due to ventilatory limitation, gas exchange abnormalities, and deconditioning as the disease progresses, and this may impair functional capacity and the quality of life.
COPD patients usually terminate physical activity when the ventilatory requirement exceeds their maximal ventilatory capacity.
If they have PH, the altered hemodynamic response may reduce their exercise capacity further.
Nowadays, despite the fact that LTOT improves the survival of hypoxaemic patients, PH is still associated with lower survival rates . Importantly, an elevated Ppa was also associated with an increased risk of severe acute exacerbation in COPD patients with moderate-to-severe airflow limitation .
Impaired exercise tolerance in COPD patients would suggest that cardiopulmonary exercise test (CPET) is a valuable tool to reveal whether they have PH or not.
Transthoracic echocardiography (TTE) is one such tool and is widely available and safe. In addition to its role in diagnosis, it can be used to screen for high-risk patient populations, to assess prognosis and to monitor disease stability and response to treatment.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amira Emad El-din
- Phone Number: +201019937498
- Email: tota_eg1993@yahoo.com
Study Contact Backup
- Name: Waleed Gamal Elddin
- Email: waleedGamalddin@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Stable COPD patients
- with age ≥ 40 years.
- Prior to inclusion, the COPD diagnosis was verified by spirometry before and after bronchodilation.
- treatment was optimized and Patients on regular medication.
Exclusion Criteria:
- Patients who refuse to participate in the study.
- Patients underwent thorough pulmonary and cardiologic preinclusion screening, and those with pulmonary disease other than COPD and emphysema.
- arrhythmia
- valvular or coronary heart disease
- left ventricle dysfunction
- obstructive sleep apnea syndrome
- pulmonary embolism
- systemic hypertension ≥160/90 mmHg
- inflammatory disease
- hyperthyroidism
- renal failure
- inability to exercise (due to orthopedic, neurologic or musculoskeletal problem).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
Time Frame: Baseline
|
For the assessment whether the existence of pulmonary hypertension in COPD is related to characteristic findings during cardiopulmonary exercise testing (CPET).
|
Baseline
|
Measurement the arterial pO2 in mmHg and arterial pCO2 at baseline
Time Frame: Baseline
|
The blood gases pO2 and pCO2 are taken to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.
Time Frame: Baseline
|
For the assessment of the symptoms of the study group and its relation to exercise capacity and the impact COPD on wellbeing and daily life - CAT score < 10 is associated with better outcome and prognosis but score = or > 10 is associated with poor outcome and prognosis.
|
Baseline
|
measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )
Time Frame: Baseline
|
measures perceived respiratory disability indicating the extent to which their breathlessness affects their mobility - dyspnoea is assessed by accepted questionnaires typically used for COPD patients at baseline- grade <2 indicates better outcome and prognosis but grade = or >2 indicates poor outcome and prognosis.
|
Baseline
|
Measurement of FEV1
Time Frame: Baseline
|
For assessment of which degrees of severity of COPD are more related to development of COPD with pulmonary hypertension.
|
Baseline
|
Measurement of Breathing reserve during cardiopulmonary exercise testing
Time Frame: Baseline
|
The breathing reserve in % is assessed at the end of the cardiopulmonary exercise testing to characterize a ventilatory limitation of the exercise test.
It is calculated as percent from the minute ventilation in relation to the maximum mandatory ventilation.
The measurement is a routine measurement during cardiopulmonary exercise testing.
|
Baseline
|
Measurement of Oxygen pulse during cardiopulmonary exercise testing
Time Frame: Baseline
|
Baseline
|
|
Presence of cardiovascular comorbidities
Time Frame: Baseline
|
For the cardiopulmonary characterization clinical characteristics, lung function, blood gases, laboratory investigation, ECG and echocardiography were used in addition to cardiopulmonary exercise testing.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Skjorten I, Hilde JM, Melsom MN, Hisdal J, Hansteen V, Steine K, Humerfelt S. Cardiopulmonary exercise test and PaO2 in evaluation of pulmonary hypertension in COPD. Int J Chron Obstruct Pulmon Dis. 2017 Dec 22;13:91-100. doi: 10.2147/COPD.S150034. eCollection 2018.
- Sarac R, Cikes I, Butkovic D, Dimov-Butkovic D. [Doppler echocardiography in the evaluation of pulmonary hypertension in chronic obstructive pulmonary disease]. Lijec Vjesn. 1995 Jan-Feb;117(1-2):9-15. Croatian.
- Habib G, Torbicki A. The role of echocardiography in the diagnosis and management of patients with pulmonary hypertension. Eur Respir Rev. 2010 Dec;19(118):288-99. doi: 10.1183/09059180.00008110.
- Holverda S, Bogaard HJ, Groepenhoff H, Postmus PE, Boonstra A, Vonk-Noordegraaf A. Cardiopulmonary exercise test characteristics in patients with chronic obstructive pulmonary disease and associated pulmonary hypertension. Respiration. 2008;76(2):160-7. doi: 10.1159/000110207. Epub 2007 Oct 25.
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPET in PH in COPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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