Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Heart Failure (HF)
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04915118
Start Date
June 17 2021
End Date
November 30 2021
Last Update
December 2 2022
Active Locations (1)
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1
Many locations
Multiple Locations, Germany