RecruitingNCT07094425

Intensive Care Unit-acquired Heart Failure in Critically Ill: the ICU-HF Study


Sponsor

Charite University, Berlin, Germany

Enrollment

50 participants

Start Date

Aug 7, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Critically ill patients in intensive care units (ICUs) are exposed to a wide range of complications that can affect long-term morbidity and mortality. Not only the initial diagnosis at the time of admission may lead to complications; the ICU stay itself can also be associated with specific disease patterns. One of the most frequent complications of intensive care treatment is the loss of skeletal muscle mass. Muscle atrophy can be detected in up to 17% of all critically ill ICU patients. This is accompanied by a neuromuscular organ dysfunction collectively referred to as Intensive Care Unit Acquired Weakness (ICUAW). Milder forms of ICUAW are present in up to 40% of all ICU patients, which corresponds to approximately 1.2 million individuals per year in Germany alone. These patients face a multitude of long-term complications and have an increased mortality risk that may persist for up to five years after ICU discharge. To date, the definition of ICUAW is limited to the skeletal musculature of critically ill patients. It remains unclear whether an ICU stay also affects other muscle groups, such as the myocardium. A first retrospective study demonstrated a significant reduction in cardiac muscle mass in critically ill ICU patients. However, the clinical implications of this loss of myocardial mass and the contributing factors remain uncertain. In addition, the patient cohort was highly heterogeneous regarding the initial diagnosis, the intensive care therapies performed (e.g., invasive ventilation), and the findings were based on a small sample size of just 44 patients. Another study investigated the association between skeletal muscle atrophy and myocardial structure in a cohort of 378 community-dwelling older adults. They showed that a decrease in skeletal muscle mass was also accompanied by a reduction in myocardial mass. Furthermore, they found a correlation between skeletal muscle atrophy and reductions in left ventricular and left atrial dimensions. However, it remains unclear whether a reduction in myocardial mass is associated with heart failure. Heart failure is associated with a significantly increased risk of long-term morbidity and mortality. The diagnosis and staging of heart failure is primarily based on morphological assessment via transthoracic echocardiography (TTE), in combination with laboratory biomarkers (e.g., NT-proBNP), and the patient's subjective functional impairment as classified by the New York Heart Association (NYHA). Identifying heart failure is clinically relevant, as optimized pharmacologic therapy can lead to significant improvements in cardiac function and positively impact long-term survival. The aim of this study is to investigate the impact of intensive care treatment on myocardial mass and to assess a potential correlation with heart failure. Measurement of myocardial mass and evaluation of heart failure will be performed via transthoracic echocardiography.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how often new heart failure develops in critically ill patients who are on a breathing machine (mechanical ventilator) in the intensive care unit (ICU). Researchers will use ultrasound and other monitoring tools to detect this condition early and understand how it affects recovery. **You may be eligible if...** - You are 18 years or older - You are a critically ill patient who has been placed on a mechanical ventilator within the first 24 hours of entering the ICU - Your ICU stay is expected to last at least 3 days **You may NOT be eligible if...** - You are not expected to survive your ICU stay, or your care has shifted to comfort-focused (palliative) treatment only - You have a known allergy to electrode gel - Ultrasound imaging is not possible due to wounds, rashes, or bandages covering the chest area - You have a pacemaker or similar device that makes bioelectrical impedance testing unsafe - You have severe narrowing of the aortic heart valve - There are language barriers preventing communication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTtransthoracic echocardiography

Transthoracic echocardiography (TTE) is a non-invasive method for assessing cardiac morphology and function. As part of the study protocol, TTE will be performed at the time of study inclusion (within the first 24 hours after ICU admission), on day 3, day 7, and day 14, followed by weekly assessments (until discharge from the ICU), as well as on the day of planned ICU or hospital discharge. To verify skeletal muscle mass in relation to myocardial mass and its changes over the course of the ICU stay, bioelectrical impedance analysis (BIA) will be performed at the time points mentioned above.


Locations(2)

Medical University of Vienna

Vienna, State of Vienna, Austria

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

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NCT07094425


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