CPC Announces Initiation of MOONRAKER Program – 3 Trials Evaluating Finerenone in Patients with Heart Failure

AURORA, CO / ACCESSWIRE / August 24, 2023 / CPC Clinical Research today announced the launch of the MOONRAKER Program, a program consisting of 3 randomized trials to evaluate the role of finerenone (KERENDIA^®) as a foundational treatment for patients with heart failure. MOONRAKER is designed to support and expand the evidence base for finerenone along with the ongoing pivotal FINEARTS-HF trial (NCT04435626).

MOONRAKER is intended to include three parallel global phase 3 pragmatic trials, which collectively plan to enroll a total of approximately 9,300 patients: REDEFINE-HF¹ (NCT06008197) testing finerenone in patients hospitalized for acute heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF); CONFIRMATION-HF² evaluating early initiation of combination therapy with finerenone and SGLT2 inhibition in patients hospitalized for acute heart failure regardless of ejection fraction; and FINALITY-HF³ assessing finerenone in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists (MRAs).

“MOONRAKER is designed to address several key objectives: extend the findings of FINEARTS-HF to a higher-risk, more acute patient population among those with HFmrEF/HFpEF; develop evidence-base for early implementation of intensive combination therapy in patients hospitalized with HF across the range of ejection fraction; and, finally to create a valuable additional treatment option for a large proportion of patients with HFrEF that that are unable to be prescribed steroidal MRAs. Collectively, these trials which form the MOONRAKER program will provide a robust evidence base supporting the use of non-steroidal MRAs, such as finerenone, across HF phenotypes and care settings. We hope that these data will inform the practice guidelines, influence implementation efforts, and ultimately improve outcomes in these high-risk populations,” said Dr. Mikhail Kosiborod, cardiologist and Vice President of Research at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, US and Principal Investigator of the MOONRAKER Program.

MOONRAKER is being operationalized through a collaboration of academic research organizations (AROs) using pragmatic approaches including streamlined data collection, simplified protocols, and synergized processes across the three trials. CPC Clinical Research, an ARO affiliated with the University of Colorado, is partnering with Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, Hospital Israelita Albert Einstein in Sao Paulo, Brazil, and prominent heart failure experts from around the world to lead the program.

“MOONRAKER is a program of multiple trials enabled by innovative design elements that incorporate several pragmatic features. Shared processes and synergies across the trials will not only add efficiency, but also reflect real world practice and support pooled and expanded analyses across the program,” said Dr. Marc P. Bonaca, cardiologist at the University of Colorado Anschutz School of Medicine, and Executive Director of CPC Clinical Research which serves as the Program sponsor and coordinating center. “Conducting a fully collaborative study in countries with different realities can produce more generalizable evidence to inform clinical practice,” said Dr. Patricia Guimaraes, Head of Cardiovascular Clinical Trials for the ARO at Hospital Israelita Albert Einstein. “Implementing pragmatic methodologies in diverse geographies reinforces the importance of international collaboration.”

CPC Clinical Research is conducting the study in collaboration with Bayer AG which is also funding the program.

CPC press contact: MOONRAKER@cpcmed.org

CPC Clinical Research & CPC Community Health

2115 N. Scranton St., Suite 2040

Aurora, CO 80045-7120

¹ Randomized trial to determine the efficacy and safety of finerenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated heart failure.

² Efficacy and safety of an early, intensive management strategy with finerenone and SGLT2 inhibitor in patients hospitalized with heart failure

³ Randomized, double-blind, placebo-controlled pragmatic study to evaluate the efficacy and safety of finerenone in patients with heart failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists

SOURCE: CPC

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