NCT03871933

Brief Summary

In the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

March 11, 2019

Last Update Submit

November 7, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

atrial fibrillationautonomic functioncardiopulmonary interaction

Outcome Measures

Primary Outcomes (1)

  • total atrial conduction time

    total atrial conduction time via tissue Doppler imaging (PA-TDI interval)

    Baseline

Secondary Outcomes (7)

  • Heart rate variability

    Baseline

  • Baroreflex sensitivity

    Baseline

  • Chemoreflex sensitivity

    Baseline

  • Deep breathing test

    Baseline

  • Ewing test

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

AECOPD

acute exacerbation of COPD

Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function

stable COPD

Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function

Interventions

Measurement of lung function, electrocardiography, echocardiography and autonomic functionOTHER

Measurement of lung function, electrocardiography, echocardiography and autonomic function

AECOPDstable COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic obstructive pulmonary disease, exacerbated or stable

You may qualify if:

  • patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave 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 hypotension, active malignant disease, active rheumatic disease

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

Location

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 ObstructiveAtrial Fibrillation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 12, 2019

Study Start

March 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)