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Tovinontrine for Heart Failure (Cycle-2-PEF 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 aims to see if tovinontrine is safe and works better than a placebo in reducing NT-proBNP levels in patients with chronic heart failure.

Who is the study for?
This trial is for adults over 18 with chronic heart failure who have symptoms like shortness of breath or fatigue, signs such as swelling or lung crackles, and a recent history of heart-related hospital visits. They must have certain levels of NT-proBNP in their blood and be on stable heart medication without changes planned post-randomization.
What is being tested?
The study tests the safety and effectiveness of Tovinontrine (CRD-750) against a placebo in reducing NT-proBNP levels among patients with chronic heart failure who still have normal or near-normal heart pumping function.
What are the potential side effects?
While specific side effects are not listed here, common side effects for treatments like Tovinontrine may include issues like nausea, headache, dizziness, low blood pressure, or potential worsening of heart failure symptoms.

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 - BNP
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tovinontrine (CRD-750)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Cardurion Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
504 Total Patients Enrolled
Gail BermanStudy DirectorSenior VP Head, Clinical Development Cardurion
1 Previous Clinical Trials
400 Total Patients Enrolled
Elizabeth Moore, DNPStudy DirectorSenior Director, Clinical Research Cardurion
1 Previous Clinical Trials
400 Total Patients Enrolled
~114 spots leftby Oct 2025
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