Exercise Capacity in COPD

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing

• Registration Number: NCT03889964
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with stable COPD	Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing	-

Primary Outcome Measures

Name	Time	Method
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)	Baseline

Secondary Outcome Measures

Name	Time	Method
Measurement of Maximum wattage during cardiopulmonary exercise testing	Baseline
Measurement of FEV1	Baseline
Presence of cardiovascular comorbidities	Baseline	For the cardiopulmonary characterization clinical characteristics, lung function, blood gases, laboratory investigation, ECG and echocardiography were used in addition to cardiopulmonary exercise testing.
N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline	Baseline	NTproBNP is analysed from peripheral venous blood to characterize potential heart failure and its relation to exercise capacity of the study subjects
measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale	Baseline	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
Measurement of Breathing reserve during cardiopulmonary exercise testing	Baseline	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.
Measurement of Oxygen pulse during cardiopulmonary exercise testing	Baseline
Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline	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

Trial Locations

Locations (1)

University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany