Heart FailureICU-HFNCT07094425
Intensive Care Unit-acquired Heart Failure in Critically Ill: the ICU-HF Study
An observational study of Heart Failure and ICUAW, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, ICUAW
- What is being tested?
- transthoracic echocardiography
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Aug 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes critically ill adults aged ≥18 years who require mechanical ventilation started within 24 hours of ICU admission and are expected to stay in the ICU for at least 3 days. Exclusion criteria are: language barriers preventing informed consent or participation; expected death during ICU stay or planned shift to best supportive care; allergy to electrode gel; inability to perform transthoracic ultrasound or bioimpedance analysis due to extensive wounds, skin conditions, or dressings; presence of implantable electronic devices (e.g., pacemakers) contraindicating bioimpedance measurement; and severe aortic valve stenosis confirmed clinically or by prior echocardiography.
Who may be able to join
- 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
Who cannot join
- Language barriers
- Expected death during ICU stay or planned transition to best supportive care
- Known allergy to electrode gel
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Nils Daum contact
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
David Wall, MD, +4314040041020, david.wall@meduniwien.ac.at
Stefan J Schaller, MD, +4314040041020, aai-research@meduniwien.ac.at
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Nils Daum, +49 30 450 631289, nils.daum@charite.de
Oliver Hunsicker, MD, oliver.hunsicker@charite.de
About this study
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.
Read more
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.
- Conditions
- Heart Failure, ICUAW
- Being tested
- transthoracic echocardiography
- Keywords
- Critical Illness
- Medical subject headings
- Heart Failure, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyDiagnostic test
Also called body impedance analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patients | Patients admitted to Intensive Care Unit Receives: Diagnostic Test: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of myocardial mass during the course of intensive care in critically ill patients, assessed by transthoracic echocardiography according to ASE/EACVI guidelines based on left ventricular wall thickness and diameter measurements.
Measured: Within 14 days
Secondary outcomes (2)
Correlation between the reduction of myocardial mass (assessed by transthoracic echocardiography) and the occurrence or progression of systolic heart failure (based on echocardiographic left ventricular ejection fraction measurements)
Measured: Within 14 days
Correlation between the reduction of myocardial mass (assessed by transthoracic echocardiography) and the occurrence or progression of diastolic heart failure (based on echocardiographic left ventricular ejection fraction measurements)
Measured: Within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start7 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Stefan J Schaller, Charite University, Berlin, Germany
- Investigators
- Stefan J Schaller, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094425
- Sponsor's protocol ID
- ICU-HF
- Acronym
- ICU-HF
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit-acquired Heart Failure in Critically Ill: the ICU-HF Study
- ClinicalTrials.gov ID
- NCT07094425
- Acronym / sponsor ID
- ICU-HF / ICU-HF
- Conditions
- Heart Failure, ICUAW
- Keywords
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients | – | Diagnostic Test: transthoracic echocardiographyPatients admitted to Intensive Care Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes critically ill adults aged ≥18 years who require mechanical ventilation started within 24 hours of ICU admission and are expected to stay in the ICU for at least 3 days. Exclusion criteria are: language barriers preventing informed consent or participation; expected death during ICU stay or planned shift to best supportive care; allergy to electrode gel; inability to perform transthoracic ultrasound or bioimpedance analysis due to extensive wounds, skin conditions, or dressings; presence of implantable electronic devices (e.g., pacemakers) contraindicating bioimpedance measurement; and severe aortic valve stenosis confirmed clinically or by prior echocardiography.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Language barriers
- Expected death during ICU stay or planned transition to best supportive care
- Known allergy to electrode gel
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiographyAlso: body impedance analysisTransthoracic 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. | Diagnostic test | Critically Ill Patients |
Primary outcome
Reduction of myocardial mass during the course of intensive care in critically ill patients, assessed by transthoracic echocardiography according to ASE/EACVI guidelines based on left ventricular wall thickness and diameter measurements.
Time frame: Within 14 days
2 secondary outcomes
Correlation between the reduction of myocardial mass (assessed by transthoracic echocardiography) and the occurrence or progression of systolic heart failure (based on echocardiographic left ventricular ejection fraction measurements)
Time frame: Within 14 days
Correlation between the reduction of myocardial mass (assessed by transthoracic echocardiography) and the occurrence or progression of diastolic heart failure (based on echocardiographic left ventricular ejection fraction measurements)
Time frame: Within 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nils Daum contact
Stefan J Schaller, MD principal investigator
Charite University, Berlin, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and ICUAW, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan J Schaller, MD (+49 30 450 631289, stefan.schaller@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of myocardial mass during the course of intensive care in critically ill patients, assessed by transthoracic echocardiography according to ASE/EACVI guidelines based on left ventricular wall thickness and diameter measurements. (time frame: Within 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.