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Tovinontrine (CRD-750) - low dose 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
Awards & highlights

Cycle-1-REF Trial 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.Check my eligibility
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.See study design
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.

Cycle-1-REF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in biomarkers from Baseline to Week 12 - NT-proBNP
Secondary outcome measures
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

Cycle-1-REF 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
4 Previous Clinical Trials
332 Total Patients Enrolled
3 Trials studying Heart Failure
320 Patients Enrolled for Heart Failure
Elizabeth Moore, DNPStudy DirectorSenior Director, Clinical Research Cardurion
1 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Heart Failure
240 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"According to the details on clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially published on March 1st, 2024 and most recently revised on March 8th, 2024."

Answered by AI

What are the potential risks of administering Tovinontrine (CRD-750) at a low dosage to individuals?

"The safety rating of Tovinontrine (CRD-750) at a low dose is placed at 2 by our team, reflecting the Phase 2 nature of this trial where existing data hints towards safety without concrete evidence on efficacy."

Answered by AI

How many individuals are actively participating in this clinical study?

"To commence the research, a total of 400 eligible participants are needed to meet the trial's criteria. Cardurion Pharmaceuticals, Inc., is spearheading this initiative across various locations such as Lnvivocure in Van Nuys, California and Jacksonville Center for Clinical Research in Florida."

Answered by AI

Are there various sites within the city conducting this research study?

"Six research facilities, such as Lnvivocure in Van Nuys, Jacksonville Center for Clinical Research in Jacksonville, and Amavita Research Services, LLC in Miami are open to potential participants."

Answered by AI

Who else is applying?

What site did they apply to?
Cardurion Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am looking for something to improve my heart failure My EF IS 20-25 My MVO2 is 15.8.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)
2024. "A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215911.
All > Miami > Fort Worth
~267 spots leftby Oct 2025
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