Lead Investigator: Stefan Koudstaal, Erasmus Medical Center Rotterdam
Title of Proposal Research: Personalized Lifetime Prediction of Survival and Treatment Benefit in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction: the LIFE-Preserved Model.
Vivli Data Request: 10499
Funding Source: Funded in part by Novo Nordisk and Astra Zeneca
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Heart failure (HF) is a serious health problem affecting millions of people worldwide. There are different types of heart failure, one of which is heart failure with preserved ejection fraction (HFpEF), where the heart doesn’t relax properly. Over time, more people are being diagnosed with HFpEF, making it important to find effective treatments.
Until recently, there were limited treatment options for HFpEF. However, new medications, like sodium glucose cotransporter-2 inhibitors (SLGT2i), which work by preventing the reabsorption of glucose in the kidneys, leading to increased excretion of glucose, sodium, and water in the urine. This in turn results in a variety of beneficial effects including lowering cardiac afterload (the pressure the heart must work against to pump blood out) and increasing cardiac efficiency. SGLT2 inhibitors have shown promising results in reducing hospital visits and improving survival in heart failure patients. The latest medical guidelines recommend using these drugs for HFpEF patients.
However, the effects of treatments can differ from patient to patient. In fact, some patients have better health outcomes, so the treatment may not be as effective for them. As a result, more people would need to receive the treatment to show a benefit on a population level, and this may not be as cost-effective. This raises the question whether all patients should receive new drugs or if they should be given only to those who need them most. Accurately predicting risk helps identify patients at the highest risk, ensuring they get the greatest benefit from preventive treatment while making the best use of healthcare resources.
Right now, the models used to predict risks and benefits for HFpEF patients are not perfect—they don’t always account for the long-term risks or accurately represent the real-world population.
This research aims to develop a new model, called the “LIFE-Preserved” model, to help doctors predict how long a patient with HFpEF might live without needing to be hospitalized. This tool will allow for identifying high-risk patients who will benefit most from preventive treatment, improving their management by facilitating personalized medicine and shared decision-making.
Requested Studies:
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057951
Sponsor ID: 1245.110
UK BIOBANK, SWEDE-HF, TOPCAT, VETERAN AFFAIRS.
Data Contributor: I WILL BRING MY OWN