A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure
Chronic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
Key Inclusion Criteria: Documented diagnosis of heart failure (HF) based on medical records. Left ventricular ejection fraction (LVEF) ≥ 35% and < 50% at Screening, or documented within the 3 months before Screening, measured by transthoracic echocardiogram (TTE) or cardiac magnetic resonance imaging (MRI). New York Heart Association (NYHA) HF Class I or II. On a stable regimen of cardiovascular medication(s) for a duration of at least 4 weeks before Screening. Key Exclusion Criteria: Hospitalized for cardiovascular causes within 3 months before Screening. Decompensated HF, acute myocarditis, hypertrophic and/or restrictive/constrictive cardiomyopathy, or moderate or severe valvular heart disease (as classified by echocardiography) at Screening or within the 3 months before Screening. Moderate tricuspid regurgitation is not exclusionary. Symptoms of angina pectoris at Screening. Severe obstructive or restrictive pulmonary pathology, including chronic obstructive pulmonary disease Gold Stage III or IV, current use of oxygen therapy, or Group 1, 3, 4, or 5 pulmonary hypertension. Group 2 pulmonary hypertension is not exclusionary. History of sustained ventricular tachycardia or atrial fibrillation/atrial flutter with a ventricular response ≥ 110 beats per minute (bpm) at the time of Screening. History of hypersensitivity to any components of the investigational product (IP). Participant has received or is expected to receive a COVID-19 vaccination within 7 days of the planned date of IP administration. For SAD cohort participants to be rolled over into the MAD stage, have experienced a dose-limiting toxicity (DLT) in a SAD cohort. Participation in another clinical study of another IP within 30 days before Screening or within 5 terminal elimination half-lives of the IP, whichever is longer. Any other clinically significant medical condition that, in the Investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study.
Sites / Locations
- Cardiology PC
- University of Alabama at Birmingham: The Kirklin Clinic
- University of Florida
- Jacksonville Center For Clinical Research - ERN - PPDS
- Tennessee Center for Clinical Trials
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we WroclawiuRecruiting
- Wojewodzki Specjalistyczny Szpital im Dr Wl Bieganskiego w Lodzi
- Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
- Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w KatowicachRecruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
- Ninewells Hospital & Medical SchoolRecruiting
- Addenbrooke's HospitalRecruiting
- University College HospitalRecruiting
- Derriford Hospital
- The Royal Liverpool University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
SAD Stage: mRNA-0184
MAD Stage: mRNA-0184
MAD Stage: Placebo
Participants will receive a single dose of mRNA-0184.
Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.
Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.