THERESE: HFpEF and 2-year Mortality of COPD Patients

Sponsor
University Hospital Olomouc (Other)
Overall Status
Recruiting
CT.gov ID
NCT04277429
Collaborator
(none)
150
2
45
75
1.7

Study Details

Study Description

Brief Summary

This study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardiac function assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Influence of hearT Failure With Preserved Ejection Fraction on 2year Mortality of Patients With cHronic obstructivE pulmonaRy disEaSE- THERESE Study
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Normal cardiac function

Normal cardiac function

Diagnostic Test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis

Heart failure with reduced ejection fraction

Heart failure with reduced ejection fraction

Diagnostic Test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis

Heart failure with preserved ejection fraction

Heart failure with preserved ejection fraction

Diagnostic Test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis

Outcome Measures

Primary Outcome Measures

  1. Mortality [2 year]

    Mortality of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Exacerbation of chronic obstructive pulmonary disease requiring hospitalization

Age 40 - 80 years

Performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG)

Long acting beta agonist (LABA)/ long acting antimuscarinic (LAMA) bronchodilator treatment

Exclusion Criteria:

Presence of major heart valve dysfunction

Documented noncompliance with treatment

Presence of active malignancy

Body mass index > 40

Interstitial lung disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Frydek Mistek Hospital Frýdek-Místek Czechia
2 University Hospital Olomou Olomouc Czechia 77900

Sponsors and Collaborators

  • University Hospital Olomouc

Investigators

  • Principal Investigator: Milan Sova, Ph.D., Department of Respiratory Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Milan Sova, Principal Investigator, Department of Respiratory Medicine, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT04277429
Other Study ID Numbers:
  • THERESE
First Posted:
Feb 20, 2020
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021