The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
303
Tablets administered orally
Tablets administered orally
Change in biomarkers from Baseline to Week 12 - NT-proBNP
The percent change in plasma NT-proBNP from Baseline to Week 12.
Time frame: Baseline to Week 12
Change in biomarkers at week 12 by treatment group - cGMP
The percent change in urine and plasma cGMP from Baseline to Week 12.
Time frame: Baseline to Week 12
Change in biomarkers at week 12 by treatment group - BNP
The percent change in BNP from Baseline to Week 12.
Time frame: Baseline to Week 12
Change in the biomarker ratio at Week 12 - NT-proBNP
The percent change in the urine and plasma cGMP to NT-proBNP ratio at week 12.
Time frame: Baseline to Week 12
Change in the biomarker ratio at Week 12 - BNP
The percent change in the urine and plasma cGMP to BNP ratio from Baseline to Week 12.
Time frame: Baseline to Week 12
The change from baseline in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Scaled 0 to 100 where lower scores represent worse health status than higher scores
Time frame: Baseline to Week 12
The change from baseline in the KCCQ-23-CSS
The proportion of patients with a ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12
Time frame: Baseline to Week 12
New York Heart Association (NYHA) classification at Week 12
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Cardurion Investigative Site
Birmingham, Alabama, United States
Cardurion Investigative Site
Little Rock, Arkansas, United States
Cardurion Investigative Site
Orange, California, United States
Cardurion Investigative Site
Torrance, California, United States
Cardurion Investigative Site
Van Nuys, California, United States
Cardurion Investigative Site
Jacksonville, Florida, United States
Cardurion Investigative Site
Miami, Florida, United States
Cardurion Investigative Site
Hazel Crest, Illinois, United States
Cardurion Investigative Site
Peoria, Illinois, United States
Cardurion Investigative Site
Alexandria, Louisiana, United States
...and 74 more locations
The post-baseline NYHA classification at Week 12
Time frame: Week 12
Treatment Emergent Adverse Events (TEAEs)
The number of participants with TEAEs including drug related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation.
Time frame: Baseline to Week 12