Heart Failure (HF)NATION-OSNCT04915118
A Study Called NATION-OS to Learn About the Link Between N-terminal proBNP (NT-proBNP) Levels and Medical Problems Due to Heart Failure (HF) in German Patients With HF
An observational study of Heart Failure (HF), run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat heart failure (HF), a condition in which the heart does not pump blood as well as it should. Research has shown that the levels of a hormone called N-terminal proBNP (NT-proBNP) in the body can be used for differential diagnosing of HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (HF)
- What is being tested?
- Decompensation event
- How many people
- 169 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jun 2021to 30 Nov 2021
- 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: Data will be collected for patients who had at least one available NT-proBNP value in the past, that was assessed in an outpatient setting exactly at 01 JAN-2016 or later and within six months after a decompensation event.
Who may be able to join
- Female or male patient, aged 18 years or older at the time of HF diagnosis
- Diagnosis of heart failure with reduced ejection fraction confirmed by echocardiography
- Patient on HFrEF standard of care treatment with guideline-based therapy
- One or more HF decompensation(s) within observation period defined as HFH or the need for IV diuretic treatment
- Signed informed consent if patient is alive at start of data collection
- At least one NT-proBNP value available prior enrollment, fulfilling the below criteria:
Show all 9Show fewer
- NT-proBNP value was assessed in an outpatient setting exactly at 01-JAN-2016 or later
- NT-proBNP value was assessed and within six months after a decompensation event within observational period.
- At time of NT-proBNP measurement patients need to be hemodynamically stable without signs of residual congestion
Who cannot join
- At time of NT-proBNP measurement
- Participation in an investigational program with interventions outside of routine clinical practice
- Awaiting heart transplantation or has/anticipates receiving an implanted ventricular assist device
- Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction) or coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention) Estimated glomerular filtration rate (eGFR) calculated based on the Modification of Diet in Renal Disease (MDRD) equation < 15 ml/min/1.73m2 or chronic dialysis
- Severe hepatic insufficiency (CHILD Pugh C)
- Acute inflammatory disease
- Malignancy
- Treatment with Vericiguat (which may be available to patients in Germany in Q3 2021 but not at time of protocol development)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NT-proBNP Assessment in a HFrEF Population in Germany
Researchers are looking for a better way to treat heart failure (HF), a condition in which the heart does not pump blood as well as it should.
Research has shown that the levels of a hormone called N-terminal proBNP (NT-proBNP) in the body can be used for differential diagnosing of HF. NT-proBNP is released by the heart when there is an increase in heart pressure. The levels of NT-proBNP can indicate whether medical problems are likely to happen due to HF. These medical problems are called "decompensation events." The higher a person's NT-proBNP levels is expected, the higher their risk of developing HF and having decompensation events.
Read more
So, the researchers in this study want to learn about NT-proBNP levels and decompensation events in German patients with a common type of HF called heart failure with reduced ejection fraction (HFrEF). In patients with HFrEF, the muscle on the left chamber of the heart does not pump blood as well as it should. The researchers will collect information from patients and their health records for about 300 adult patients in Germany with HFrEF who have been receiving standard of care treatment for their condition. Standard of care treatments are treatments that doctors commonly use to treat patients.
The researchers will study and record the levels of NT-proBNP levels and any changes in the health of the patients at time of NT-proBNP measurement.
The researchers will collect this information between May 2021 and September 2021.
The patients in this study :
- have had any HF-decompensation event since January 2016
- have had at least 1 NT-proBNP measurement done before the study
The researchers will collect the following information about the patients:
- the results of NT-proBNP measurements
- the date of the NT-proBNP measurements
- the number and type of decompensation events
- Conditions
- Heart Failure (HF)
- Being tested
- Decompensation event
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompensation eventOther
Also called Biomarker
NT-proBNP (N-terminal pro B-type natriuretic) peptide distribution in patients with HFrEF who had a previous decompensation event.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HFrEF | Patients with HFrEF (Heart failure with reduced ejection fraction) who had a previous decompensation event. Receives: Other: Decompensation event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of NT-proBNP < 5314pg/ml
Range of NT-proBNP values and the proportion of NT-proBNP < 5314pg/ml in patients with HFrEF who had a previous decompensation event.
The first NT-proBNP value, will be described via summary statistics, as well as by a frequency table based on categorized NT-proBNP values. The summary statistics as well as the proportion of patients within different NT-proBNP categories (i.e. </>=5314pg/ml) will be presented overall and stratified by number of decompensation event during observation period.
Measured: within 6 months after decompensation event
Range of NT-proBNP values
Range of NT-proBNP values and the proportion of NT-proBNP < 5314pg/ml in patients with HFrEF who had a previous decompensation event.
The first NT-proBNP value, will be described via summary statistics, as well as by a frequency table based on categorized NT-proBNP values. The summary statistics as well as the proportion of patients within different NT-proBNP categories (i.e. </>=5314pg/ml) will be presented overall and stratified by number of decompensation event during observation period.
Measured: within 6 months after decompensation event
Secondary outcomes (2)
Range of NT-proBNP values across demographic characteristics
Demographic characteristics will be described by frequency tables and/or summary statistics. The patients´ medical history conditions will be displayed by a frequency table. Patients with specific prior and concomitant medication will be presented by frequency tables.
The standard of care for heart failure treatment (including Beta Blocker, Diuretics, ACEi or ARB, MRA, Sacubitril/Valsartan, ICD, Biventricular Pacemaker) will be tabulated by patient frequencies.
Measured: within 6 months after decompensation event
Range of NT-proBNP values across clinical patient characteristics
Patient characteristics (e.g. comorbidities, HFH, NYHA class) will be described by frequency tables and/or summary statistics. The patients´ medical history conditions will be displayed by a frequency table. Patients with specific prior and concomitant medication will be presented by frequency tables.
The standard of care for heart failure treatment (including Beta Blocker, Diuretics, ACEi or ARB, MRA, Sacubitril/Valsartan, ICD, Biventricular Pacemaker) will be tabulated by patient frequencies.
Measured: within 6 months after decompensation event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start17 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915118
- Sponsor's protocol ID
- 21868
- Acronym
- NATION-OS
- Status last verified
- Nov 2022
- First submitted
- 11 May 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-proBNP Assessment in a HFrEF Population in Germany
- ClinicalTrials.gov ID
- NCT04915118
- Acronym / sponsor ID
- NATION-OS / 21868
- Conditions
- Heart Failure (HF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Jun 2021 (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.
Researchers are looking for a better way to treat heart failure (HF), a condition in which the heart does not pump blood as well as it should.
Research has shown that the levels of a hormone called N-terminal proBNP (NT-proBNP) in the body can be used for differential diagnosing of HF. NT-proBNP is released by the heart when there is an increase in heart pressure. The levels of NT-proBNP can indicate whether medical problems are likely to happen due to HF. These medical problems are called "decompensation events." The higher a person's NT-proBNP levels is expected, the higher their risk of developing HF and having decompensation events.
So, the researchers in this study want to learn about NT-proBNP levels and decompensation events in German patients with a common type of HF called heart failure with reduced ejection fraction (HFrEF). In patients with HFrEF, the muscle on the left chamber of the heart does not pump blood as well as it should. The researchers will collect information from patients and their health records for about 300 adult patients in Germany with HFrEF who have been receiving standard of care treatment for their condition. Standard of care treatments are treatments that doctors commonly use to treat patients.
The researchers will study and record the levels of NT-proBNP levels and any changes in the health of the patients at time of NT-proBNP measurement.
The researchers will collect this information between May 2021 and September 2021.
The patients in this study :
- have had any HF-decompensation event since January 2016
- have had at least 1 NT-proBNP measurement done before the study
The researchers will collect the following information about the patients:
- the results of NT-proBNP measurements
- the date of the NT-proBNP measurements
- the number and type of decompensation events
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HFrEF | – | Other: Decompensation eventPatients with HFrEF (Heart failure with reduced ejection fraction) who had a previous decompensation event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected for patients who had at least one available NT-proBNP value in the past, that was assessed in an outpatient setting exactly at 01 JAN-2016 or later and within six months after a decompensation event.
Key inclusion criteria (9 listed)
- Female or male patient, aged 18 years or older at the time of HF diagnosis
- Diagnosis of heart failure with reduced ejection fraction confirmed by echocardiography
- Patient on HFrEF standard of care treatment with guideline-based therapy
- One or more HF decompensation(s) within observation period defined as HFH or the need for IV diuretic treatment
- Signed informed consent if patient is alive at start of data collection
Key exclusion criteria (8 listed)
- At time of NT-proBNP measurement
- Participation in an investigational program with interventions outside of routine clinical practice
- Awaiting heart transplantation or has/anticipates receiving an implanted ventricular assist device
- Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction) or coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention) Estimated glomerular filtration rate (eGFR) calculated based on the Modification of Diet in Renal Disease (MDRD) equation < 15 ml/min/1.73m2 or chronic dialysis
- Severe hepatic insufficiency (CHILD Pugh C)
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 |
|---|---|---|
| Decompensation eventAlso: BiomarkerNT-proBNP (N-terminal pro B-type natriuretic) peptide distribution in patients with HFrEF who had a previous decompensation event. | Other | Patients with HFrEF |
Primary outcome
Proportion of NT-proBNP < 5314pg/ml
Time frame: within 6 months after decompensation event
Range of NT-proBNP values and the proportion of NT-proBNP < 5314pg/ml in patients with HFrEF who had a previous decompensation event. The first NT-proBNP value, will be described via summary statistics, as well as by a frequency table based on categorized NT-proBNP values. The summary statistics as well as the proportion of patients within different NT-proBNP categories (i.e. </>=5314pg/ml) will be presented overall and stratified by number of decompensation event during observation period.
Range of NT-proBNP values
Time frame: within 6 months after decompensation event
Range of NT-proBNP values and the proportion of NT-proBNP < 5314pg/ml in patients with HFrEF who had a previous decompensation event. The first NT-proBNP value, will be described via summary statistics, as well as by a frequency table based on categorized NT-proBNP values. The summary statistics as well as the proportion of patients within different NT-proBNP categories (i.e. </>=5314pg/ml) will be presented overall and stratified by number of decompensation event during observation period.
2 secondary outcomes
Range of NT-proBNP values across demographic characteristics
Time frame: within 6 months after decompensation event
Range of NT-proBNP values across clinical patient characteristics
Time frame: within 6 months after decompensation event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (HF), run by Bayer 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 2 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of NT-proBNP < 5314pg/ml (time frame: within 6 months after decompensation event). 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 2 Dec 2022.