NCT03889964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

March 11, 2019

Last Update Submit

February 10, 2020

Conditions

Keywords

cardiopulmonary exercise testingcardiovascular comorbiditiescardiopulmonary interaction

Outcome Measures

Primary Outcomes (1)

  • Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)

    Baseline

Secondary Outcomes (8)

  • measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale

    Baseline

  • Measurement of FEV1

    Baseline

  • Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline

    Baseline

  • N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline

    Baseline

  • Measurement of Maximum wattage during cardiopulmonary exercise testing

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

patients with stable COPD

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

Interventions

Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing

patients with stable COPD

Eligibility Criteria

Age40 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with stabile chronic obstructive pulmonary disease

You may qualify if:

  • patients with stable chronic obstructive pulmonary disease, exacerbated or stable
  • years
  • sinus rhythm
  • informed written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of 20 ml of peripheral blood Clinical routine such as NTproBNP, renal function, thyroid function, blood count

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Central Study Contacts

Rabea Wagstaff, M.A.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 26, 2019

Study Start

March 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations