Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital

NCT06597331 | Recruiting

• 1 other identifier: Dnr 2024-02071-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)?
2. 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?

Conditions

Chronic Obstructive Pulmonary Disease; Takotsubo Cardiomyopathy; Acute Heart Failure

Keywords

Takotsubo syndrome; COPD; Echocardiography; Screening; Trigger

Outcome Measures

Primary Outcomes (2)

• Reversible left ventricular dysfunction (myocardial stunning) according to echocardiography

  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

  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 Outcomes (3)

• In-hospital Major Adverse Cardiac Events (MACE)

  At discharge from hospital (on average 5 days)

• Admission to intensive care unit (ICU) during index hospitalization

  At discharge from hospital (on average 5 days)

• In-hospital death and death within one year

  At time of in-hospital death or at discharge from hospital (on average 5 days) and after 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adult patients (≥ 18 years old) admitted to hospital ward for AE-COPD
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Emergency Medicine and Geriatrics, Sahlgrenska University Hospital/S

Gothenburg, Region Västra Götaland, 41345, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, biobanking for later analysis of metabolomics, proteomics, miRNA and mRNA

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Rickard Zeijlon, M.D. PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rickard Zeijlon, M.D. PhD

CONTACT

+46705821889; rickard.zeijlon@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, specialist of internal medicine

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)