CPET in Evaluation of PH in COPD Patients

NCT ID: NCT04035148

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-31

Brief Summary

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* 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

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(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

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COPD Pulmonary Hypertension Secondary

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Cardiopulmonary exercise test

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Echocardiography pulmonary function test blood gases Electrocardiography

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amira Emad El-din Abdalah

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amira Emad El-din

Role: CONTACT

+201019937498

Waleed Gamal Elddin

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 29339921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7651072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21119187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17960052 (View on PubMed)

Related Links

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Other Identifiers

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CPET in PH in COPD

Identifier Type: -

Identifier Source: org_study_id

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