check_circleStudy Completed

Heart failure (HF)

Bayer Identifier:

21868

ClinicalTrials.gov Identifier:

NCT04915118

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • 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 summary

Enrollment Goal
169
Trial Dates
June 2021 - November 2021
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Many locationsMany locations, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    within 6 months after decompensation event

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    within 6 months after decompensation event

Trial design

NT-proBNP assessment in a HFrEF population in Germany
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A