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Tovinontrine for Heart Failure (Cycle-1-REF Trial)

Phase 2
Recruiting
Research Sponsored by Cardurion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12

Summary

This trial will test if tovinontrine is safe and works well in reducing NT-proBNP levels in patients with chronic heart failure and reduced ejection fraction, compared to a placebo.

Who is the study for?
This trial is for adults with chronic heart failure who have a reduced ability of the heart to pump blood (ejection fraction ≤ 40%). Participants must show certain levels of NT-proBNP, a marker indicating heart stress, and have symptoms or signs of heart failure. They should be on stable heart failure medication for at least 4 weeks with no recent changes.
What is being tested?
The study tests Tovinontrine's effectiveness in lowering NT-proBNP levels compared to a placebo in patients with chronic heart failure. The goal is to see if Tovinontrine can improve symptoms by helping the failing heart work better.
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to Tovinontrine or general issues associated with clinical trials such as injection site reactions, nausea, headaches, or other unforeseen complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in biomarkers from Baseline to Week 12 - NT-proBNP
Secondary study objectives
Assessment of pharmacokinetics (PK): PK effect on NT-proBNP
Assessment of pharmacokinetics (PK): PK effect on plasma cGMP
Change in biomarkers at Week 12 by treatment group - NT-proBNP
+15 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tovinontrine (CRD-750) - medium doseExperimental Treatment1 Intervention
Group II: Tovinontrine (CRD-750) - low doseExperimental Treatment1 Intervention
Group III: Tovinontrine (CRD-750) - high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Cardurion Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
344 Total Patients Enrolled
Gail BermanStudy DirectorSenior VP Head, Clinical Development Cardurion
1 Previous Clinical Trials
240 Total Patients Enrolled
Elizabeth Moore, DNPStudy DirectorSenior Director, Clinical Research Cardurion
1 Previous Clinical Trials
240 Total Patients Enrolled
~189 spots leftby Oct 2025
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