Chronic Cardiovascular DiseaseNCT07385482
Chronic and Acute Cardiovascular Diseases in Elderly Intensive Care Patients
An observational study of Chronic Cardiovascular Disease and Acute Cardiovascular Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Chronic Cardiovascular Disease, Acute Cardiovascular Disease, Frailty
- How many people
- 4,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2026to 1 Mar 2027
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study focuses on older intensive care unit patients with chronic and acute cardiovascular diseases and is coordinated across multiple international sites using standardized data collection procedures.
Who may be able to join
- 80 years or older
- Admission to the intensive care unit
- Signed informed consent or absence of discernible indications suggesting the presumed intention of the patient not to participate in the study.
Who cannot join
- < 80 years
- Absence of informed consent
- Discernible indications suggesting the presumed intention of the patient not to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Duesseldorf
Düsseldorf
Christian Jund, MD, +492118118567, Christian.jung@med.uni-duesseldorf.de
Lisa Dannenberg, MD, + 49211 81 05315, LisaKristina.Dannenberg@med.uni-duesseldorf.de
About this study
Official title: Impact of Chronic and Acute Cardiovascular Diseases in Older Intensive Care Patients: A Prospective Multicenter Observational Study - VIP4
Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.
Read the detailed description
The primary aim of this prospective multicenter observational study is to investigate the impact of chronic and acute cardiovascular diseases on the clinical phenotype, short-term outcomes, and long-term functional trajectories of older intensive care unit (ICU) patients. The main hypothesis is that patients with chronic or acute cardiovascular diseases differ in their pre-ICU clinical phenotype and have a higher risk of adverse short-term outcomes and impaired long-term functional recovery compared with patients without these conditions. Using the established international VIP research network, older ICU patients will be assessed multidimensionally using validated instruments and routinely collected clinical data across different ICU specialties (cardiac, cardio-surgical, internal medicine, and surgical ICUs) and healthcare systems.
The primary endpoint of the study is 6-month all-cause mortality. Secondary endpoints include functional status and health-related quality of life during follow-up.
Pre-existing comorbidities will be captured using the AHRQ Elixhauser Comorbidity Index, with detailed documentation of chronic cardiovascular comorbidities and medication history. Frailty and functional status will be assessed using the Clinical Frailty Scale and the Katz Index, while baseline cognitive function will be evaluated using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Health-related quality of life prior to the acute illness will be assessed using the EQ-5D-5L. Nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI) and the Global Leadership Initiative on Malnutrition (GLIM) criteria (e.g. body weight and dietary history) At ICU admission and during the ICU stay, routinely available laboratory parameters including albumin, lactate, international normalized ratio (INR), HbA1c, and hemoglobin will be recorded. Disease severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score at admission and during follow-up. Data on ICU interventions, including invasive mechanical ventilation, vasopressor therapy, renal replacement therapy, mechanical circulatory support, enteral and parenteral nutrition, and physiotherapy, will be documented. Hemoglobin levels at ICU admission and discharge as well as the highest and lowest values during the ICU stay will be captured.
Approximately 4,000 patients are planned to be enrolled within 12 months, allowing predefined subgroup analyses according to age, sex, frailty status, and cognitive function using advanced exploratory analytical approaches. The study aims to contribute to closing the existing evidence gap regarding chronic and acute cardiovascular disease in older critically ill patients
- Keywords
- older intensive care patients, intensive care unit, cardiovascular disease, frailty, multimorbidity, mortality, functional outcome, health-related quality of life
- Medical subject headings
- Frailty, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
surivival or death
Measured: within 6 months
Secondary outcomes (4)
Functionality and Quality of Life
measured by clinical fraility scale: Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse health status
Measured: 6 months
Functionality and Quality of Life
measured by katz acitivies of daily living (assessment of ability to perform daily activities): Scores range from 0 to 6, with higher scores indicating greater independence and better functional status
Measured: 6 months
Functionality and Quality of Life
measured by EQ-5D-5L (assessment of health-related quality of life): Individual response patterns will be reported as EQ-5D-5L health states (e.g., 11111 indicating no problems in all five dimensions), allowing a descriptive assessment of dimension-specific limitations
Measured: 6 months
Long-term survival and readmission rate
Long-term survival and readmission rate
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital DuesseldorfChristian Jung, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385482
- Sponsor's protocol ID
- VIP4
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic and Acute Cardiovascular Diseases in Older Intensive Care Patients: A Prospective Multicenter Observational Study - VIP4
- ClinicalTrials.gov ID
- NCT07385482
- Acronym / sponsor ID
- VIP4
- Keywords
- older intensive care patients, intensive care unit, cardiovascular disease, frailty, multimorbidity, mortality, functional outcome, health-related quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.
Detailed description
The primary aim of this prospective multicenter observational study is to investigate the impact of chronic and acute cardiovascular diseases on the clinical phenotype, short-term outcomes, and long-term functional trajectories of older intensive care unit (ICU) patients. The main hypothesis is that patients with chronic or acute cardiovascular diseases differ in their pre-ICU clinical phenotype and have a higher risk of adverse short-term outcomes and impaired long-term functional recovery compared with patients without these conditions. Using the established international VIP research network, older ICU patients will be assessed multidimensionally using validated instruments and routinely collected clinical data across different ICU specialties (cardiac, cardio-surgical, internal medicine, and surgical ICUs) and healthcare systems.
The primary endpoint of the study is 6-month all-cause mortality. Secondary endpoints include functional status and health-related quality of life during follow-up.
Pre-existing comorbidities will be captured using the AHRQ Elixhauser Comorbidity Index, with detailed documentation of chronic cardiovascular comorbidities and medication history. Frailty and functional status will be assessed using the Clinical Frailty Scale and the Katz Index, while baseline cognitive function will be evaluated using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Health-related quality of life prior to the acute illness will be assessed using the EQ-5D-5L. Nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI) and the Global Leadership Initiative on Malnutrition (GLIM) criteria (e.g. body weight and dietary history) At ICU admission and during the ICU stay, routinely available laboratory parameters including albumin, lactate, international normalized ratio (INR), HbA1c, and hemoglobin will be recorded. Disease severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score at admission and during follow-up. Data on ICU interventions, including invasive mechanical ventilation, vasopressor therapy, renal replacement therapy, mechanical circulatory support, enteral and parenteral nutrition, and physiotherapy, will be documented. Hemoglobin levels at ICU admission and discharge as well as the highest and lowest values during the ICU stay will be captured.
Approximately 4,000 patients are planned to be enrolled within 12 months, allowing predefined subgroup analyses according to age, sex, frailty status, and cognitive function using advanced exploratory analytical approaches. The study aims to contribute to closing the existing evidence gap regarding chronic and acute cardiovascular disease in older critically ill patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study focuses on older intensive care unit patients with chronic and acute cardiovascular diseases and is coordinated across multiple international sites using standardized data collection procedures.
Key inclusion criteria (3 listed)
- 80 years or older
- Admission to the intensive care unit
- Signed informed consent or absence of discernible indications suggesting the presumed intention of the patient not to participate in the study.
Key exclusion criteria (3 listed)
- < 80 years
- Absence of informed consent
- Discernible indications suggesting the presumed intention of the patient not to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: within 6 months
surivival or death
4 secondary outcomes
Functionality and Quality of Life
Time frame: 6 months
Functionality and Quality of Life
Time frame: 6 months
Functionality and Quality of Life
Time frame: 6 months
Long-term survival and readmission rate
Time frame: up to 12 months
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 5 Feb 2026.
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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.
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Christian Jung, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cardiovascular Disease and Acute Cardiovascular Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Christian Jung, MD (+492118118567, Christian.jung@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: within 6 months). 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 5 Feb 2026.