Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital (CATCH)

May 9, 2025 updated by: Rickard Zeijlon, Sahlgrenska University Hospital

Prospective Observational Study of Myocardial Stunning in Patients Hospitalized for Exacerbation of Chronic Obstructive Pulmonary Disease

The goal of this prospective observational study is to investigate to what extent acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) triggers Takotsubo-stunning, and how this affects the outcome for these patients.

The main questions it aims to answer are:

  1. What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)?
  2. Among patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S, what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

PURPOSE

The purpose of Cardiac Assessment and Takotsubo-stunning among COPD-exacerbations in-Hospital (CATCH) is to investigate to what extent AE-COPD triggers Takotsubo-stunning in patients admitted to in-hospital care, and how this affects the outcome for these patients.

BACKGROUND

Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) may cause acute heart failure due to stress-induced myocardial stunning, which is probably underdiagnosed or undiagnosed in clinical routine. Elements of myocardial stunning is associated with several conditions, however, the Takotsubo syndrome (TS) is probably a pure form of myocardial stunning. Therefore, the term "Takotsubo-stunning" is sometimes used to describe the myocardial stunning that occur in TS.

TS is an acute heart failure syndrome associated with emotional or physical stress predominately affecting females (>90% females) in the postmenopausal ages. TS is characterized by rapid onset of regional wall motion abnormality (typically widespread apical akinesia) and reversible left ventricular dysfunction. One of the most widely reported physical triggers of TS is AE-COPD and COPD is overrepresented among patients with TS. Concurrent respiratory disease such as AE-COPD complicate the diagnosis of TS, since the cardiac condition may be masked by pulmonary symptoms, and the respiratory symptoms may be further exacerbated by Takotsubo-stunning. Also, a cornerstone in the treatment for AE-COPD is high doses of beta-2-adrenergic agonists through inhalation. This may be unfavourable (and possibly detrimental) for a patient with Takotsubo-stunning, since adrenergic overstimulation in general, and overstimulation of cardiac beta-2-adrenergic receptor in particular, seems to be involved in the pathophysiology of TS.

Although it is known that AE-COPD is common among patients with TS, research is lacking regarding the inverse relationship, i.e. how common TS is among patients with AE-COPD. Therefore, the investigators aim to elucidate to what extent AE-COPD triggers Takotsubo-stunning, through investigating the incidence of Takotsubo-stunning in AE-COPD.

HYPOTHESES

  1. Among adult patients admitted for in-hospital care for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden) a non-negligible proportion (more than one out of ten) develop Takotsubo-stunning as complication triggered by the AE-COPD.
  2. Within in the above-mentioned patient group, AE-COPD complicated by Takotsubo-stunning is associated with more clinical signs of acute heart failure and a worse outcome (longer length of stay, more complications, higher mortality) compared to AE-COPD not complicated by TS.

STUDY DESIGN

CATCH is a prospective observational cohort study, originating from the section for Acute and Cardiovascular Medicine at the department of Emergency Medicine and Geriatrics at Sahlgrenska University Hospital/S (SU/S). Patients admitted to SU/S hospital wards 90 or 91 (acute internal medicine); 19 or 32 (pulmonary medicine and general internal medicine); 16 or 29 (endocrinology and gastroenterology) for AE-COPD are eligible for inclusion.

To identify possible Takotsubo-stunning, included patients will be screened for echocardiographic signs of regional wall motion abnormality and/or left ventricular dysfunction, where positive and negative screening will be defined as follows:

POSITIVE: Presence of any regional wall motion abnormality and/or left ventricular dysfunction (LVEF <50%)

NEGATIVE: Absence of regional wall motion abnormality and no left ventricular dysfunction (LVEF >50%)

If negative, screening will be repeated once, after 24 (+/-6) hours. If positive (i.e. screening reveals signs of regional wall motion abnormality and/or cardiac dysfunction), screening will be converted to a full echocardiographic examination according to standard clinical protocol, which will be repeated after 24 (+/-6) hours and after 30 (+/-48 hours) days. Reversibility will be defined as improvement in cardiac function between first positive echocardiographic examination and day 30. Such transient cardiac dysfunction will be regarded as Takotsubo-stunning (provided no other cause has been identified, as per diagnostic criteria for TS). Persistent cardiac dysfunction is a pre-defined exclusion-criteria and therefore these patients will be excluded from the analysis. Patients who turn out positive in screening will be offered inclusion in STAMI-study (Stunning in Takotsubo versus Acute Myocardial Infarction, clinical trials identifier NCT04448639, ongoing since 2020).

OTHER PROCEDURES AND COLLECTION OF DATA

All patients will be interviewed according to a questionnaire regarding presenting symptoms. Blood sampling for analysis of NTproBNP, ECG and chest x-ray will be performed at inclusion (day 0) and day 1. Baseline characteristics will be collected from the patients' medical charts and vital parameters will be registered the first three days. In-hospital complications/death will be registered consecutively. COPD GOLD (Global initiative for Obstructive Lung Disease) grade/group and severity of exacerbation will be registered. In follow-up, data from re-evaluation of COPD (clinical routine after hospital care for AE-COPD) will be collected (Spirometry, diffusion capacity, static lung volumes, 6-min walk test. COPD assessment test).

PRIMARY ENDPOINTS

  1. 1-year cumulative incidence of Takotsubo-stunning
  2. Clinical signs of acute heart failure during hospitalization (defined as modified Killip Class >1, explained below)

Modified Killip Class: To assess clinical signs heart failure, the investigators will use a modified version of Killip Classification of acute heart failure (originally developed for assessing acute heart failure after myocardial infarction). Killip class I-III will be assessed using pulmonary ultrasound instead of auscultation sounds, Killip Class IV (cardiogenic shock) will be assessed unmodified according to clinical routine.

SECONDARY ENDPOINTS

  1. In-hospital Major Adverse Cardiac Events (MACE): nonfatal myocardial infarction, nonfatal stroke or cardiovascular death
  2. Admission to intensive care unit
  3. In-hospital death and death within one year

SCIENTIFIC IMPORTANCE

A link seems to exist between AE-COPD and myocardial stunning/TS. This is important for two main reasons:

  1. The cardiac condition may be masked by the respiratory symptoms and the clinical signs of AE-COPD, leading to delayed or missed diagnosis of the cardiac component
  2. Myocardial stunning with cardiac dysfunction may further exacerbate the patient's condition, leading to prolonged time to recovery due to concomitant untreated AHF; and an increased risk of severe cardiac complications

Another important aspect is the treatment for AE-COPD, which may include treatment with high doses of beta-2-agonists. Catecholamines are part of the pathophysiological cause of myocardial stunning, and catecholaminergic drugs may further aggravate myocardial stunning. In fact, beta-2-agonists specifically has been shown to likely trigger myocardial stunning/TS. Therefore, the routine treatment for AE-COPD may be associated with a risk of harming patients with concomitant AE-COPD and myocardial stunning. If successful, the CATCH-study may improve the quality of care and outcome for patients with AE-COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
    • Region Västra Götaland
      • Gothenburg, Region Västra Götaland, Sweden, 41345
        • Recruiting
        • Department of Emergency Medicine and Geriatrics, Sahlgrenska University Hospital/S
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rickard Zeijlon, MD, PhD
        • Sub-Investigator:
          • Johan-Emil Bager, MD, PhD
        • Sub-Investigator:
          • Emma Westerlind, MD, PhD
        • Sub-Investigator:
          • Peter Hällgren Nordhage, MD
        • Sub-Investigator:
          • Angela Poller, MSc,PhD-stud
        • Sub-Investigator:
          • Sandeep Jha, MD, PhD-stud
        • Sub-Investigator:
          • Sigurdur James Thorleifsson, MD, PhD-stud
        • Sub-Investigator:
          • Sara Zooq, MD
        • Sub-Investigator:
          • Johan Lönnbro, MD, PhD
        • Sub-Investigator:
          • Björn Redfors, MD,Professor
        • Sub-Investigator:
          • Lowie Vanfleeteren, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients admitted to hospital ward for AE-COPD within 72 hours

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years old) admitted to hospital ward for AE-COPD
  • Inclusion within 72 hours of admission,
  • Written informed consent

Exclusion Criteria:

  • Prior acute myocardial infarction or known pre-existing persistent regional wall motion abnormality or left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%)
  • Expected inability to comply with the protocol (e.g. dementia)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reversible left ventricular dysfunction (myocardial stunning) according to echocardiography
Time Frame: 30 days
Echocardiographic signs of myocardial stunning/Takotsubo-stunning at inclusion (day 0) with recovery of left ventricular function at day 1 and/or day 30
30 days
Clinical signs of acute heart failure at inclusion (day 0) or day 1 according to the Killip Classification
Time Frame: 2 days
Acute heart failure will be defined as modified Killip Class >1, and will be compared between patients with vs without myocardial stunning/Takotsubo-stunning
2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital Major Adverse Cardiac Events (MACE)
Time Frame: At discharge from hospital (on average 5 days)
Defined as nonfatal myocardial infarction, nonfatal stroke or cardiovascular death; at some point during hospitalization. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
At discharge from hospital (on average 5 days)
Admission to intensive care unit (ICU) during index hospitalization
Time Frame: At discharge from hospital (on average 5 days)
Admission to ICU at any point during hospitalization. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
At discharge from hospital (on average 5 days)
In-hospital death and death within one year
Time Frame: At time of in-hospital death or at discharge from hospital (on average 5 days) and after 1 year
In-hospital death and death within one year. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
At time of in-hospital death or at discharge from hospital (on average 5 days) and after 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahlgrenska University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rickard Zeijlon, M.D. PhD, Sahlgrenska University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2024-02071-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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