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

Conditions

chronic heart failure

Brief summary

The percent change from baseline (pre-dose on Day 1) in plasma NT-proBNP at Week 12.

Detailed description

The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP at Week 12, The percent change from baseline (pre-dose on Day 1) in BNP at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to NT-proBNP ratio at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to BNP ratio at Week 12, The change from baseline (pre-dose on Day 1) in the KCCQ-23-CSS, KCCQ-23-OSS, and 8 domains (physical limitation, symptom stability, symptom frequency, symptom burden, total symptom score, quality of life, self-efficacy, and social limitation) at Week 12, The change from baseline (pre-dose on Day 1) of the proportion of patients with ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12, The post-baseline NYHA classification at Week 12

Related papers

No related papers found yet.

Interventions

DRUGtovinontrine-matching placebo

DRUGimmediate-release tablet

DRUGTovinontrine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The percent change from baseline (pre-dose on Day 1) in plasma NT-proBNP at Week 12.	—

Secondary

Measure	Time frame
The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP at Week 12, The percent change from baseline (pre-dose on Day 1) in BNP at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to NT-proBNP ratio at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to BNP ratio at Week 12, The change from baseline (pre-dose on Day 1) in the KCCQ-23-CSS, KCCQ-23-OSS, and 8 domains (physical limitation, symptom stability, symptom frequency, symptom burden, total symptom score, quality of life, self-efficacy, and social limitation) at Week 12, The change from baseline (pre-dose on Day 1) of the proportion of patients with ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12, The post-baseline NYHA classification at Week 12	—

Measure

Time frame

The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP at Week 12, The percent change from baseline (pre-dose on Day 1) in BNP at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to NT-proBNP ratio at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to BNP ratio at Week 12, The change from baseline (pre-dose on Day 1) in the KCCQ-23-CSS, KCCQ-23-OSS, and 8 domains (physical limitation, symptom stability, symptom frequency, symptom burden, total symptom score, quality of life, self-efficacy, and social limitation) at Week 12, The change from baseline (pre-dose on Day 1) of the proportion of patients with ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12, The post-baseline NYHA classification at Week 12

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Countries

Belgium, Bulgaria, Czechia, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed