Exercise Capacity in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Reduced Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease -Relevance of Cardiovascular Comorbidities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889964
• Other study ID #: 17-033
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Stefanie Keymel, MD
• Phone: +492118118800
• Email: ctsu[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity.

Description:

In patients with chronic obstructive pulmonary disease (COPD) the interpretation of dyspnoea also needs to consider coexisting cardiovascular disease. Cardiopulmonary exercise testing (CPET) is used to characterize pulmonary and cardiac function and limitations during exercise. The investigators hypothesise that cardiopulmonary exercise is reduced in COPD patients with coexisting cardiovascular disease as well as in more symptomatic patients and in patients with frequent exacerbations. For this purpose, 100 patients with with stable COPD are characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Gender: All
• Age group: 40 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients with stable chronic obstructive pulmonary disease, exacerbated or stable

• 40-80 years

• sinus rhythm

• informed written consent

Exclusion Criteria:

• Inability to give written consent

• acute myocardial infarction with ST-segment elevations in last 30 days

• severe acute or chronic renal dysfunction

• severe heart failure-

• atrial fibrillation

• severe valve disease

• severe hypoxemia

• long term oxygen therapy or non invasive ventilation

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing
Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing

Locations

Country	Name	City	State
Germany	University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)		Baseline
Secondary	measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale	For the assessment of the symptoms of the study group and its relation to exercise capacity dyspnoea is assessed by accepted questionnaires typically used for COPD patients at baseline	Baseline
Secondary	Measurement of FEV1		Baseline
Secondary	Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline	The blood gases pO2 and pCO2 are taken from the hyperaemic ear lobe to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure	Baseline
Secondary	N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline	NTproBNP is analysed from peripheral venous blood to characterize potential heart failure and its relation to exercise capacity of the study subjects	Baseline
Secondary	Measurement of Maximum wattage during cardiopulmonary exercise testing		Baseline
Secondary	Measurement of Breathing reserve during cardiopulmonary exercise testing	BThe 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
Secondary	Measurement of Oxygen pulse during cardiopulmonary exercise testing		Baseline
Secondary	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.	Baseline