Heart FailureNCT06272578
Screen CardRen - A Cross-sectional Observational Cohort Study
An observational study of Heart Failure and Chronic Kidney Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases
- What is being tested?
- Echocardiography
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population will comprise 400 adult patients with chronic kidney disease, defined as elevated urine albumin to creatinine ratio (UACR > 30 mg/g or >3 mg/mmol) or reduced estimated glomerular filtration rate (eGFR < 60 ml/min/1.73m²) at a one-time measurement. In addition to renal function impairment, study participants will either have a background of cardiovascular risk factors, including arterial hypertension, type 2 diabetes mellitus or hypercholesterolemia.
Who may be able to join
- Chronic Kidney Disease, stages G1-G4, AND
- Estimated glomerular filtration rate (eGFR) as determined by the 2009 CKD-EPI Cr equation ≥ 60 ml/min/1.73m², if UACR ≥30 mg/g (≥3 mg/mmol) OR
- eGFR according to CKD-EPI 2009 Cr equation < 60 ml/min/1.73m², but > 15 ml/min/1.73m²
- Diabetes mellitus type 2 OR
- Pathological findings in oral glucose tolerance test (≥ 200 mg/dl (2h)) OR
- documented HbA1c ≥ 6.5 % OR
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- Intake of any antidiabetic medication (in case of previously established diagnosis of Diabetes mellitus type 2) OR
- Fasting blood glucose ≥ 126 mg/dl
- Arterial Hypertension Grade ≥ 1 OR
- Blood pressure of ≥ 140/90 mmHg, defined according to the 2018 ESC guidelines on arterial hypertension (Williams) OR
- Intake of antihypertensive drugs
- Hypercholesterolemia OR
- LDL-cholesterol > 130mg/dl OR
- Intake of a lipid-lowering medication initiated to treat dyslipoptroteinemia
Who cannot join
- History of acute kidney injury > stage 1 according to KDIGO criteria in the two weeks prior to study visit
- Chronic kidney disease Stage 5 (end-stage renal disease)
- Previous diagnosis of chronic heart failure
- Acute myocardial infarction in the past 30 days prior to study visit
- Stroke in the past 30 days prior to study visit
- Known congenital heart disease
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- Previous diagnosis of a specific cardiomyopathy, infiltrative cardiac disease, pericardial constriction, sarcoidosis, amyloidosis and other storage diseases
- Implanted cardiac devices, such as pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices
- Implanted mechanical valve prosthesis
- Inability to give informed consent
- Lack of health insurance
- Organ transplanted
- Intake of immunosuppressive medication
- Major surgery in the 6 months before study visit, such as cardiac bypass surgery or valve replacement surgery (thoracotomy), major vascular surgery (such as replacement of aortic root, ascending part, aortic arch or any part of the abdominal aorta), major abdominal surgery (e.g. Whipple procedure, colorectal resection, gastrectomy and others) or limb amputation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Center Charité (DHZC)
Wedding, State of Berlin, 13353
Manuela Riedl, manuela.riedl@dhzc-charite.de
Fabian Spinka, MD, fabian.spinka@dhzc-charite.de
About this study
Official title: A Cross-sectional Observational Cohort Study to Evaluate the Prevalence of Asymptomatic Cardiac Structural Abnormalities and Cardiac Dysfunction in a Contemporary Outpatient at Risk Population With Chronic Kidney Disease
In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure.
Read the detailed description
Background/Rationale:
Chronic kidney disease and cardiovascular disease share a large set of risk factors, such as arterial hypertension, type 2 diabetes mellitus and dyslipidaemia. Chronic kidney disease, even in early stages, further increases the risk for cardiovascular diseases such as heart failure.
Objectives and Hypotheses:
In this single-centre, cross-sectional study, the investigators will aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes. The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure.
Methods:
Study design: single-centre, cross-sectional, non-interventional study Data Source(s): electronic case report form containing patient history, clinical status and physical examination, imaging data from echocardiography, air displacement plethysmography data, plasma proteome data obtained from Olink technology-based analysis of blood samples Study Population: Adult chronic kidney disease patients with additional cardiovascular risk factors (at least one of the following: arterial hypertension, type 2 diabetes mellitus, and dyslipidaemia). The inclusion criteria are further defined in the corresponding section of the study protocol.
Exposure(s): chronic kidney disease and cardiovascular risk factors such as arterial hypertension, type 2 diabetes mellitus, dyslipidaemia, or atherosclerotic vascular disease
Outcome(s):
Primary objective:
- Assess the frequency of stage B heart failure as indicated by structural or functional cardiac abnormalities assessed by echocardiography and/or corresponding laboratory parameters
Secondary objectives:
- Identification of possible predictive parameters for significant cardiac dysfunction (Heart Failure Stage B) in a contemporary at risk cohort with renal dysfunction, based on imaging and proteomics data
- Building of the Berlin-Brandenburg prevention network to improve the intersectional cooperation to identify, diagnose and follow-up risk patients
- Establishment of tools like US.2 AI, electronic health records, central data management in order to enable a fast construction while working resource-friendly
- Follow-up of risk patients based on mobile sensors/apps
- Adoption of screening in standard care Sample Size Estimations: The study is focused on the estimation of the prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction in a contemporary at risk cohort with chronic kidney disease. Therefore, the investigators will calculate the corresponding two-sided 95% confidence interval. With a sample size of 400 patients, a two-sided 95% confidence interval for an assumed prevalence of 30% can be determined with an extension of ± 4%.
Statistical Analysis:
Objectives will be analyzed according to their scaling and distribution characteristics, including appropriate descriptive location and variability parameters and 95% confidence intervals. Additionally, multiple regression analyses will be performed in order to identify potential risk factors for significant cardiac dysfunction.
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Being tested
- Echocardiography
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction
Transthoracic echocardiographic measurements are the primary outcome parameters and will be conducted according to the current recommendations for cardiac chamber quantification of the American Society of Echocardiography and the European Association of Cardiovascular Imaging, the latest update on left ventricular diastolic function assessment and recommendations on aortic stenosis quantification.
Measured: 1 year
Proteomic analysis
Proteomic analysis will be performed using Olink technology, which is based on proximity extension assay (PEA) technology combined with next generation sequencing. This method has demonstrated accuracy and sensitivity in detecting minute quantities of proteins (sub-pg/ml), making it suitable for conducting extensive multiplex assays covering a wide dynamic range. In this study, plasma samples
Measured: 1 year
Secondary outcomes (3)
Duration of echocardiographic examination
The duration of echocardiographic examination as mean, median, standard deviation, quantiles and range in comparison between portable and cart-based device
Measured: 1 year
Time saved by portable echocardiography and automated image analysis
Amount of time savings in minutes as mean, median, standard deviation, quantiles and range in comparison between portable device and automated image analysis, potential impact on waiting period for patients requiring echocardiography
Measured: 1 year
Image quality of cart-based vs. portable echo images
The number of echocardiographic examinations with acceptable image quality as frequencies and percentages in comparison between devices
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024
- Primary completion27 Feb 2025 (estimated)
- Study completion30 Jun 2025 (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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Frank Edelmann, Charite University, Berlin, Germany
- Investigators
- Frank Edelmann, Prof. Dr., Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272578
- Sponsor's protocol ID
- 20021405
- Status last verified
- Aug 2024
- First submitted
- 5 Dec 2023
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Observational Cohort Study to Evaluate the Prevalence of Asymptomatic Cardiac Structural Abnormalities and Cardiac Dysfunction in a Contemporary Outpatient at Risk Population With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06272578
- Acronym / sponsor ID
- 20021405
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure.
Detailed description
Background/Rationale:
Chronic kidney disease and cardiovascular disease share a large set of risk factors, such as arterial hypertension, type 2 diabetes mellitus and dyslipidaemia. Chronic kidney disease, even in early stages, further increases the risk for cardiovascular diseases such as heart failure.
Objectives and Hypotheses:
In this single-centre, cross-sectional study, the investigators will aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes. The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure.
Methods:
Study design: single-centre, cross-sectional, non-interventional study Data Source(s): electronic case report form containing patient history, clinical status and physical examination, imaging data from echocardiography, air displacement plethysmography data, plasma proteome data obtained from Olink technology-based analysis of blood samples Study Population: Adult chronic kidney disease patients with additional cardiovascular risk factors (at least one of the following: arterial hypertension, type 2 diabetes mellitus, and dyslipidaemia). The inclusion criteria are further defined in the corresponding section of the study protocol.
Exposure(s): chronic kidney disease and cardiovascular risk factors such as arterial hypertension, type 2 diabetes mellitus, dyslipidaemia, or atherosclerotic vascular disease
Outcome(s):
Primary objective:
- Assess the frequency of stage B heart failure as indicated by structural or functional cardiac abnormalities assessed by echocardiography and/or corresponding laboratory parameters
Secondary objectives:
- Identification of possible predictive parameters for significant cardiac dysfunction (Heart Failure Stage B) in a contemporary at risk cohort with renal dysfunction, based on imaging and proteomics data
- Building of the Berlin-Brandenburg prevention network to improve the intersectional cooperation to identify, diagnose and follow-up risk patients
- Establishment of tools like US.2 AI, electronic health records, central data management in order to enable a fast construction while working resource-friendly
- Follow-up of risk patients based on mobile sensors/apps
- Adoption of screening in standard care Sample Size Estimations: The study is focused on the estimation of the prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction in a contemporary at risk cohort with chronic kidney disease. Therefore, the investigators will calculate the corresponding two-sided 95% confidence interval. With a sample size of 400 patients, a two-sided 95% confidence interval for an assumed prevalence of 30% can be determined with an extension of ± 4%.
Statistical Analysis:
Objectives will be analyzed according to their scaling and distribution characteristics, including appropriate descriptive location and variability parameters and 95% confidence intervals. Additionally, multiple regression analyses will be performed in order to identify potential risk factors for significant cardiac dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise 400 adult patients with chronic kidney disease, defined as elevated urine albumin to creatinine ratio (UACR > 30 mg/g or >3 mg/mmol) or reduced estimated glomerular filtration rate (eGFR < 60 ml/min/1.73m²) at a one-time measurement. In addition to renal function impairment, study participants will either have a background of cardiovascular risk factors, including arterial hypertension, type 2 diabetes mellitus or hypercholesterolemia.
Key inclusion criteria (14 listed)
- Chronic Kidney Disease, stages G1-G4, AND
- Estimated glomerular filtration rate (eGFR) as determined by the 2009 CKD-EPI Cr equation ≥ 60 ml/min/1.73m², if UACR ≥30 mg/g (≥3 mg/mmol) OR
- eGFR according to CKD-EPI 2009 Cr equation < 60 ml/min/1.73m², but > 15 ml/min/1.73m²
- Diabetes mellitus type 2 OR
- Pathological findings in oral glucose tolerance test (≥ 200 mg/dl (2h)) OR
Key exclusion criteria (14 listed)
- History of acute kidney injury > stage 1 according to KDIGO criteria in the two weeks prior to study visit
- Chronic kidney disease Stage 5 (end-stage renal disease)
- Previous diagnosis of chronic heart failure
- Acute myocardial infarction in the past 30 days prior to study visit
- Stroke in the past 30 days prior to study visit
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 |
|---|---|---|
| EchocardiographyEchocardiography | Diagnostic test | – |
Primary outcome
prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction
Time frame: 1 year
Transthoracic echocardiographic measurements are the primary outcome parameters and will be conducted according to the current recommendations for cardiac chamber quantification of the American Society of Echocardiography and the European Association of Cardiovascular Imaging, the latest update on left ventricular diastolic function assessment and recommendations on aortic stenosis quantification.
Proteomic analysis
Time frame: 1 year
Proteomic analysis will be performed using Olink technology, which is based on proximity extension assay (PEA) technology combined with next generation sequencing. This method has demonstrated accuracy and sensitivity in detecting minute quantities of proteins (sub-pg/ml), making it suitable for conducting extensive multiplex assays covering a wide dynamic range. In this study, plasma samples
3 secondary outcomes
Duration of echocardiographic examination
Time frame: 1 year
Time saved by portable echocardiography and automated image analysis
Time frame: 1 year
Image quality of cart-based vs. portable echo images
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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. This study is not recruiting at the moment.
Frank Edelmann, Prof. Dr. principal investigator
German Heart Institute
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 Heart Failure and Chronic Kidney Diseases, run by Charite University, Berlin, Germany 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 14 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Zurkan (+49 30 450 665 374, daniela.zurkan@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction (time frame: 1 year). The study lists 2 primary outcomes in all. 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 21 Aug 2024.