Clinical trial NCT03889964: Exercise Capacity in COPD
Official title: Reduced Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease -Relevance of Cardiovascular Comorbidities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: cardiopulmonary exercise testing
cardiovascular comorbidities
cardiopulmonary interaction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stabile chronic obstructive pulmonary disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
timeFrame: Baseline
Secondary outcomes:
measure: measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale
timeFrame: Baseline
measure: Measurement of FEV1
timeFrame: Baseline
measure: Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline
timeFrame: Baseline
measure: N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline
timeFrame: Baseline
measure: Measurement of Maximum wattage during cardiopulmonary exercise testing
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:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References: