Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
Placebo
mRNA-0184
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Documented diagnosis of heart failure (HF) based on medical records.
Left ventricular ejection fraction (LVEF) ≥ 35% and < 50% at Screening, ordocumented within the 3 months before Screening, measured by transthoracicechocardiogram (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 4weeks before Screening.
Exclusion
Key Exclusion Criteria:
Hospitalized for cardiovascular causes within 3 months before Screening.
Decompensated HF, acute myocarditis, hypertrophic and/or restrictive/constrictivecardiomyopathy, or moderate or severe valvular heart disease (as classified byechocardiography) at Screening or within the 3 months before Screening. Moderatetricuspid regurgitation is not exclusionary. Congenital heart disease as the primaryetiology for heart failure will be excluded.
Symptoms of angina pectoris at Screening.
Severe obstructive or restrictive pulmonary pathology, including chronic obstructivepulmonary 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 notexclusionary.
History of sustained ventricular tachycardia or atrial fibrillation/atrial flutterwith 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 7days of the planned date of IP administration.
For SAD cohort participants to be rolled over into the MAD stage, have experienced adose-limiting toxicity (DLT) in a SAD cohort.
Participation in another clinical study of another IP within 30 days beforeScreening or within 5 terminal elimination half-lives of the IP, whichever islonger.
Any other clinically significant medical condition that, in the Investigator'sopinion, could interfere with the interpretation of study results or limit theparticipant's participation in the study, including poorly controlled diabetesmellitus.
Study Design
Study Description
Connect with a study center
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Dolnoslaskie 50-556
PolandSite Not Available
Wojewodzki Specjalistyczny Szpital im Dr Wl Bieganskiego w Lodzi
Lódz, Lódzkie 91-347
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opolskie 45-401
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie 15-276
PolandSite Not Available
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach
Katowice, Slaskie 40-635
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Wielkopolskie 61-848
PolandSite Not Available
Ninewells Hospital & Medical School
Dundee, Angus DD1 9SY
United KingdomSite Not Available
Addenbrooke's Hospital
Cambridge, Cambridgeshire CB2 0QQ
United KingdomSite Not Available
University College Hospital
London, City Of London NW1 2BU
United KingdomSite Not Available
Derriford Hospital
Plymouth, Devon PL6 8DH
United KingdomSite Not Available
The Royal Liverpool University Hospital
Liverpool, L7 8XP
United KingdomSite Not Available
Cardiology PC
Birmingham, Alabama 35211
United StatesSite Not Available
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama 35233
United StatesSite Not Available
University of Florida
Gainesville, Florida 32608
United StatesSite Not Available
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida 32216
United StatesSite Not Available
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
United StatesSite Not Available
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