Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise

Sponsor

LHL Helse (Other)

Overall Status

Completed

CT.gov ID

NCT02721693

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.

Condition or Disease	Intervention/Treatment	Phase
COPD Myocardial Diseases	Device: Treadmill exercise test	N/A

Detailed Description

Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

COPD, Physical Exercise and Troponin T

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treadmill exercise test Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion	Device: Treadmill exercise test Patients are subjected to an incremental exercise test to exhaustion on a treadmill

Arm

Intervention/Treatment

Experimental: Treadmill exercise test

Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion

Device: Treadmill exercise test

Patients are subjected to an incremental exercise test to exhaustion on a treadmill

Outcome Measures

Primary Outcome Measures

Troponin T concentration 3 h [3 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COPD
GOLD 2-4
BODE-index ≥ 2
Referred by physician to a CPET

Exclusion Criteria:

Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
Percutaneous coronary intervention (PCI)
Hypertension that is not controlled

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LHL-klinikkene	Hakadal	Akershus	Norway	1485

Sponsors and Collaborators

LHL Helse

Investigators

Principal Investigator: Anne H Edvardsen, PhD, LHL Helse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anne Helene Edvardsen, Head of Out Patient and Laboratory Department, Researcher, LHL Helse

ClinicalTrials.gov Identifier:

NCT02721693

Other Study ID Numbers:

2016/23140

First Posted:

Mar 29, 2016

Last Update Posted:

Oct 11, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Anne Helene Edvardsen, Head of Out Patient and Laboratory Department, Researcher, LHL Helse

Troponin

Exercise

Additional relevant MeSH terms:

Cardiomyopathies

Study Results

No Results Posted as of Oct 11, 2016