Clinical trial NCT04915118: 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
Official title: NT-proBNP Assessment in a HFrEF Population in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure (HF)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* 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:

  * 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

Exclusion Criteria:

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)

Primary outcomes:
measure: Proportion of NT-proBNP < 5314pg/ml
timeFrame: within 6 months after decompensation event
measure: Range of NT-proBNP values
timeFrame: within 6 months after decompensation event
Secondary outcomes:
measure: Range of NT-proBNP values across demographic characteristics
timeFrame: within 6 months after decompensation event
measure: Range of NT-proBNP values across clinical patient characteristics
timeFrame: within 6 months after decompensation event
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: