COPDNCT04035148
CPET in Evaluation of PH in COPD Patients
An observational study of COPD and Pulmonary Hypertension Secondary, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Pulmonary Hypertension Secondary
- What is being tested?
- Cardiopulmonary exercise test
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with stable chronic obstructive pulmonary disease
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- pulmonary embolism
- systemic hypertension ≥160/90 mmHg
- inflammatory disease
- hyperthyroidism
- renal failure
- inability to exercise (due to orthopedic, neurologic or musculoskeletal problem).
Trial locations and contacts
No sites are listed yet.
Waleed Gamal Elddin contact
About this study
Official title: 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).
Read the 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.
- Conditions
- COPD, Pulmonary Hypertension Secondary
- Being tested
- Cardiopulmonary exercise test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testDiagnostic test
Also called Echocardiography, pulmonary function test, blood gases, Electrocardiography
we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.Transthoracic Echocardiography(TTE) : The first step non-invasive method to diagnose PHT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
For the assessment whether the existence of pulmonary hypertension in COPD is related to characteristic findings during cardiopulmonary exercise testing (CPET).
Measured: Baseline
Measurement the arterial pO2 in mmHg and arterial pCO2 at baseline
The blood gases pO2 and pCO2 are taken to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure
Measured: Baseline
Secondary outcomes (6)
measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.
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.
Measured: Baseline
measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )
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.
Measured: Baseline
Measurement of FEV1
For assessment of which degrees of severity of COPD are more related to development of COPD with pulmonary hypertension.
Measured: Baseline
Measurement of Breathing reserve during cardiopulmonary exercise testing
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.
Measured: Baseline
Measurement of Oxygen pulse during cardiopulmonary exercise testing
Measured: Baseline
Presence of cardiovascular comorbidities
For the cardiopulmonary characterization clinical characteristics, lung function, blood gases, laboratory investigation, ECG and echocardiography were used in addition to cardiopulmonary exercise testing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Emad El-din Abdalah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035148
- Sponsor's protocol ID
- CPET in PH in COPD
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29339921Sarac 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.
PubMed 7651072Habib 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.
PubMed 21119187Holverda 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.
PubMed 17960052
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Test in Evaluation of Pulmonary Hypertension in COPD Patients
- ClinicalTrials.gov ID
- NCT04035148
- Acronym / sponsor ID
- CPET in PH in COPD
- Conditions
- COPD, Pulmonary Hypertension Secondary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stable chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testAlso: Echocardiography, pulmonary function test, blood gases, Electrocardiographywe prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.Transthoracic Echocardiography(TTE) : The first step non-invasive method to diagnose PHT. | Diagnostic test | – |
Primary outcome
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).
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
6 secondary outcomes
measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.
Time frame: Baseline
measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )
Time frame: Baseline
Measurement of FEV1
Time frame: Baseline
Measurement of Breathing reserve during cardiopulmonary exercise testing
Time frame: Baseline
Measurement of Oxygen pulse during cardiopulmonary exercise testing
Time frame: Baseline
Presence of cardiovascular comorbidities
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 29339921Skjorten 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.
- Background: PubMed 7651072Sarac 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.
- Background: PubMed 21119187Habib 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.
- Background: PubMed 17960052Holverda 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.
- Holverda S et al. Respiration. (2008)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Gamal Elddin contact
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pulmonary Hypertension Secondary, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Emad El-din (+201019937498, tota_eg1993@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.