HFpEF and 2-year Mortality of COPD Patients (THERESE)

November 1, 2022 updated by: Milan Sova, University Hospital Olomouc

The Influence of hearT Failure With Preserved Ejection Fraction on 2year Mortality of Patients With cHronic obstructivE pulmonaRy disEaSE- THERESE Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Frýdek-Místek, Czechia
        • Not yet recruiting
        • Frydek Mistek Hospital
        • Contact:
      • Olomouc, Czechia, 77900
        • Recruiting
        • University Hospital Olomou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal cardiac function
Diagnostic test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis
Heart failure with reduced ejection fraction
Diagnostic test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis
Heart failure with preserved ejection fraction
Diagnostic test: Cardiac function assessment
Echocardiography, cardiac enzymes analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 2 year
Mortality of patients
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THERESE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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