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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New York Heart Association (NYHA) HF Class I or II
Documented diagnosis of heart failure (HF) based on medical records
Must not have
Hospitalized for cardiovascular causes within 3 months before Screening
History of sustained ventricular tachycardia or atrial fibrillation/atrial flutter with a ventricular response ≥ 110 beats per minute (bpm) at the time of Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (within 60 minutes predose) up to day 183
Awards & highlights
Summary
This trial tests the safety of a potential new medicine when taken at different doses.
Who is the study for?
This trial is for adults with heart failure who have been on stable heart medication for at least 4 weeks. They should have a left ventricular ejection fraction between 35% and <50%, fall under NYHA HF Class I or II, and not be hospitalized for cardiovascular reasons recently. People can't join if they've had recent COVID-19 vaccination, angina symptoms, severe allergies to the drug's components, other clinical study participation recently, uncontrolled diabetes, certain heart diseases or severe lung problems.Check my eligibility
What is being tested?
The trial is testing mRNA-0184 against a placebo in people with chronic heart failure. It aims to find out how safe it is and how well participants tolerate different doses of this new treatment when given once or multiple times.See study design
What are the potential side effects?
Since the study focuses on safety and tolerability of mRNA-0184 in patients with heart failure, potential side effects are being investigated but are not specified here. Common side effects may include reactions at injection site, flu-like symptoms among others typical for vaccine-related interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart failure is mild to moderate.
Select...
I have been officially diagnosed with heart failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was hospitalized for heart-related issues within the last 3 months.
Select...
I have had a fast heartbeat due to irregular rhythms in the past.
Select...
I experience chest pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (within 60 minutes predose) up to day 183
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (within 60 minutes predose) up to day 183
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA
Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein
Maximum Observed Effect (Emax) of Rel2- vlk Protein
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Stage: mRNA-0184Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-0184.
Group II: MAD Stage: mRNA-0184Experimental Treatment1 Intervention
Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.
Group III: MAD Stage: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,866 Total Patients Enrolled
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