CPET in Evaluation of PH in COPD Patients

NCT04035148 | Unknown

• 1 other identifier: CPET in PH in COPD
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

COPD; Pulmonary Hypertension Secondary

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  Baseline

Secondary Outcomes (6)

• measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.

  Baseline

• measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )

  Baseline

• Measurement of FEV1

  Baseline

• Measurement of Breathing reserve during cardiopulmonary exercise testing

  Baseline

• Measurement of Oxygen pulse during cardiopulmonary exercise testing

  Baseline

Interventions

Cardiopulmonary exercise test DIAGNOSTIC_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.

Also known as: Echocardiography, pulmonary function test, blood gases, Electrocardiography

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable chronic obstructive pulmonary disease

You may qualify if:

• Stable COPD patients
• with age ≥ 40 years.
• treatment was optimized and Patients on regular medication.

You may not qualify if:

• Patients who refuse to participate in the study.
• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 29339921 BACKGROUND

• 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.

  PMID: 7651072 BACKGROUND

• 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.

  PMID: 21119187 BACKGROUND

• 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.

  PMID: 17960052 BACKGROUND

Related Links

• Holverda S et al. Respiration. (2008)

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test; Echocardiography; Respiratory Function Tests; Blood Gas Analysis; Electrocardiography

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Electrodiagnosis

Central Study Contacts

Amira Emad El-din

CONTACT

+201019937498; tota_eg1993@yahoo.com

Waleed Gamal Elddin

CONTACT

waleedGamalddin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 29, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: July 30, 2019

Record last verified: 2019-07