Clinical trial NCT04035148: CPET in Evaluation of PH in COPD Patients
Official title: Cardiopulmonary Exercise Test in Evaluation of Pulmonary Hypertension in COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Pulmonary Hypertension Secondary
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable chronic obstructive pulmonary disease

Brief 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.
* 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
timeFrame: Baseline
measure: Measurement the arterial pO2 in mmHg and arterial pCO2 at baseline
timeFrame: Baseline
Secondary outcomes:
measure: measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.
timeFrame: Baseline
measure: measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )
timeFrame: Baseline
measure: Measurement of FEV1
timeFrame: Baseline
measure: Measurement of Breathing reserve during cardiopulmonary exercise testing
timeFrame: Baseline
measure: Measurement of Oxygen pulse during cardiopulmonary exercise testing
timeFrame: Baseline
measure: Presence of cardiovascular comorbidities
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.