NCT07094425: ICU-HF

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

Recruiting now Last updated 13 August 2025

What this trial tests

trial testing transthoracic echocardiography in Heart Failure in 50 participants. Currently enrolling.

Timeline

7 August 2025

Primary endpoint
1 August 2026

1 November 2026

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	50
Start date	7 August 2025
Primary completion	1 August 2026
Estimated completion	1 November 2026
Sites	2 locations across Austria, Germany

Drugs / interventions tested

• transthoracic echocardiography

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• ICUAW — all drugs for ICUAW →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Heart Failure or ICUAW. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.