Chronic Obstructive Pulmonary DiseaseTHERESENCT04277429
HFpEF and 2-year Mortality of COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease and Heart Failure, run by University Hospital Olomouc at 2 sites in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Heart Failure
- What is being tested?
- Cardiac function assessment
- How many people
- 150 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jul 2020to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease
Who may be able to join
- 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
Who cannot join
- Presence of major heart valve dysfunction
- Documented noncompliance with treatment
- Presence of active malignancy
- Body mass index > 40
- Interstitial lung disease
Trial locations and contacts
2 sites in 1 country.
Ondrej Zela, MD contact
Czechia2 sites, 2 recruiting
- Not yet recruiting
Frydek Mistek Hospital
Frýdek-Místek
Ondrej Zela, zela@nemfm.cz
- Recruiting
University Hospital Olomou
Olomouc, 77900
Milan Sova, 588445326, milan.sova@fnol.cz
About this study
Official title: 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
- Being tested
- Cardiac function assessment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac function assessmentDiagnostic test
Echocardiography, cardiac enzymes analysis
| Study group | Role | What they receive |
|---|---|---|
| Normal cardiac function | Normal cardiac function Receives: Diagnostic Test: Cardiac function assessment | |
| Heart failure with reduced ejection fraction | Heart failure with reduced ejection fraction Receives: Diagnostic Test: Cardiac function assessment | |
| Heart failure with preserved ejection fraction | Heart failure with preserved ejection fraction Receives: Diagnostic Test: Cardiac function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality of patients
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jul 2020
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milan Sova, University Hospital Olomouc
- Investigators
- Milan Sova, Ph.D., Principal investigator, Department of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277429
- Sponsor's protocol ID
- THERESE
- Acronym
- THERESE
- Status last verified
- Nov 2022
- First submitted
- 17 Feb 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of hearT Failure With Preserved Ejection Fraction on 2year Mortality of Patients With cHronic obstructivE pulmonaRy disEaSE- THERESE Study
- ClinicalTrials.gov ID
- NCT04277429
- Acronym / sponsor ID
- THERESE / THERESE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal cardiac function | – | Diagnostic Test: Cardiac function assessmentNormal cardiac function |
| Heart failure with reduced ejection fraction | – | Diagnostic Test: Cardiac function assessmentHeart failure with reduced ejection fraction |
| Heart failure with preserved ejection fraction | – | Diagnostic Test: Cardiac function assessmentHeart failure with preserved ejection fraction |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Presence of major heart valve dysfunction
- Documented noncompliance with treatment
- Presence of active malignancy
- Body mass index > 40
- Interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac function assessmentEchocardiography, cardiac enzymes analysis | Diagnostic test | Heart failure with preserved ejection fraction, Heart failure with reduced ejection fraction, Normal cardiac function |
Primary outcome
Mortality
Time frame: 2 year
Mortality of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Zela, MD contact
Milan Sova, Ph.D. principal investigator
Department of Respiratory Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Heart Failure, run by University Hospital Olomouc at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milan Sova, Ph.D. (588445326, milan.sova@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.