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

COPD Clinical Trial

Official title:

COPD, Physical Exercise and Troponin T

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721693
• Other study ID #: 2016/23140
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: October 10, 2016
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• COPD
• Myocardial Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Treadmill exercise test
Patients are subjected to an incremental exercise test to exhaustion on a treadmill

Locations

Country	Name	City	State
Norway	LHL-klinikkene	Hakadal	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
LHL Helse

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin T concentration 3 h		3 h	No