NCT07094425Recruiting
Intensive Care Unit-acquired Heart Failure in Critically Ill: the ICU-HF Study
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 18 Jul 2025
- Start date
- 7 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Heart failure
- NCT number
- NCT07094425
What you commit to
- Study type: Observational
- Planned participants: 50
- From 7 Aug 2025 to the primary completion date, 1 Aug 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to electrode gel
Other
- Language barriers
- Expected death during ICU stay or planned transition to best supportive care
- Ultrasound not technically feasible (e.g., due to extensive wounds, skin rash, or dressings)
- Patients with a pacemaker or similar electronic devices for whom bioelectrical impedance analysis (BIA) is contraindicated
- Patients with severe aortic valve stenosis
Who the study is looking for
- Critically ill patients aged ≥ 18 years
- Initiation of mechanical ventilation within the first 24 hours after ICU admission
- Expected duration of ICU stay of at least 3 days
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.