Sign up to receive posts from The Exchange
Posted By: Daniel Thibodeau, MHP, PA-C
May 26, 2020
As we look to improve the treatment and quality of life of our patients with heart failure, we often use relevant labs to help us determine the extent of the disease. In addition, the use of clinical trials helps us understand how lab values can influence treatment options and therapies for our patients. An example of this is brain natriuretic peptide, or BNP, and N-terminal-proBNP (NT-proBNP). The measurement of this biomarker allows an understanding of the stretch receptors in cardiac tissue that can be released when volume overload is happening, which signifies worsening heart failure. However, clinical trials have been erratic in their use of measuring BNP, and there is no standard consensus on how it should be used as an inclusion criteria for these trials. In the May 2020 issue of the Journal of the American College of Cardiology: Heart Failure, a position paper researched this problem and has come up with suggestions to improve the inclusion criteria for trials. Within this document, the researchers have made some solid recommendations that will help future research to standardize the criteria for inclusion of patients and their BNP levels. These recommendations include:
- Ensure enrollment of patients who have an accurate diagnosis of heart failure
- Ensure enrollment of patients with acute heart failure who are presenting with nonspecific symptoms
- Adjust BNP levels for special populations (eg, atrial fibrillation, renal failure, elderly, obese)
- Adjust BNP concentrations for the desired event rates of the trials
Why does this matter to all of us? The trials that we depend on to give us the best, up to date information and treatment options must be inclusive and representative of our patients. A standard approach to inclusion criteria gives us the best chance to ensure the research will better represent our patient populations.
These recommendations can positively impact the way clinical trials use BNP and NT-proBNP inclusion criteria and improve the overall research process. Having a standardized inclusion criteria for patient population in these studies will hopefully improve our ability to care for our patients with heart failure.
- Ibrahim NE, Burnett JC, Butler J, et al. Natriuretic peptides as inclusion criteria in clinical trials: A JACC: Heart Failure position paper. JACC: Heart Failure. 2020;8:347-358.
Filed under: Cardiometabolic