A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction

This is a Phase 2, study to study the safety and efficacy of 50 mg of tovinontrine in adult patients with Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The primary endpoint (measurement of what happens to people in the clinical trial) will assess the change in NT-proBNP blood level over 12 weeks compared to placebo. NT-proBNP level in blood is an indicator (biomarker) of effectiveness of the treatment. NT-proBNP has been used as a biomarker in other Phase 2 HF studies, including those testing a drug available on the market called Entresto, working in a similar way in the body as tovinontrine.There is a sound scientific and medical rationale for the development of PDE9 inhibitors (such as tovinotrine) for HF. Nevertheless, there may not be any clinical benefit from taking part in this research study. However, the results of this research will benefit science and may guide the future treatment of patients with HF. The study will include a placebo arm (sham treatment). A placebo arm is considered necessary because NT-proBNP may change during the course of the study without additional drug intervention, and therefore, an objective comparison of the effect of each tovinontrine dose level with placebo-treated patients is necessary. Further, to ensure adequate treatment for study patients, standard-of-care medications for HF treatment are not excluded during study participation. Taking into account the measures taken to mitigate risk to patients in this study, the potential risks identified in association with tovinontrine are justified by the anticipated potential benefits that may be afforded to patients with HFpEF.