The objective of this proposal is to validate a multivariable prediction model that was previously generated to identify patients with heart failure preserved ejection fraction (HFpEF) who are at a high risk of sudden cardiac death (SCD). Heart failure with preserved ejection fraction (HFpEF) is a major public health problem affecting 3 million people in the U.S., constituting 60% of all heart failure patients. However, in sharp contrast with heart failure reduced ejection fraction (HFrEF), there are yet no treatments proven to improve the survival of patients with HFpEF. Carefully-conducted randomized clinical trials have shown that 24%-28% of patients with HFpEF die due to sudden cardiac death (SCD), which is the most prevalent mode of cardiovascular death in HFpEF, surpassing pump failure. Thus, therapies to reduce SCD are necessary to reach the ultimate goal of improving survival in HFpEF. We previously generated (and published) a multivariable prediction model to identify patients with HFpEF who are at high risk of SCD using the Irbesartan in Patients with Heart Failure Preserved Ejection Fraction (I-PRESERVE) trial database. The HFpEF patients identified by this multivariable risk model had as high a risk of SCD as patients with HFrEF who are currently eligible for implantable cardioverter-defibrillator therapy. In the current proposal, we seek to validate this prediction model in an independent cohort; namely the Spironolactone for Heart Failure with Preserved Ejection Fraction (TOPCAT) trial database. Validation of the multivariable prediction model for SCD in an independent cohort is a critical step to allow its use for risk stratification. If validated in the TOPCAT trial population the multivariable prediction model that we have generated can be used as an entrance criterion for a randomized clinical trial testing the efficacy of interventions designed to prevent SCD in HFpEF.
|Effective start/end date||07/01/2017 → 06/30/2019|