Heart failure patients get RNA boost during bypass in first human test
NCT ID NCT06621576
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a single injection of HM2002, a circular RNA, given directly into the heart muscle during bypass surgery. Only 3 people with heart failure took part. The main goal was to check safety, not to prove it works. The study is complete, but results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
3 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects must meet all of the following inclusion criteria: 1. be ≥18 and ≤80 years of age at the time of signing the informative and be of either sex; 2. have ischemic heart failure (IHF) with left ventricular ejection fraction (LVEF) ≤50% by echocardiography (ECHO), New York Heart Association (NYHA) cardiac function class 3-4, and be proposed to undergo elective coronary artery bypass grafting (CABG); 3. voluntarily sign the informed consent form and fully understand the content, process and possible adverse reactions of the trial. Be able to complete the study according to the requirements of the trial protocol and have good compliance; Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from this study: 1. subjects with the following concomitant symptoms or diseases: 1. ECHO-confirmed LVEF ≤ 20%; 2. History of malignant arrhythmias (including multiple ventricular pre-systole, premature ventricular dystocia, tricyclic rhythm, or ventricular tachycardia) manifesting symptomatically or requiring treatment (CTCAE grade 3); 3. atrial fibrillation (including paroxysmal atrial fibrillation); 4. Long QT syndrome; 5. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2; f. Serum gammaglutamyl (GGT) ≤ 1.5 mL/min/1.73 m2 6. Serum alanine aminotransferase (ALT) or aminotransferase (AST) \> 3 x upper limit normal (ULN) and total bilirubin (TBIL) \> 2 x ULN or more; 7. Severe coagulation disorders, bleeding disorders, etc; 8. history of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV); active HIV, HCV, and HBV infections are defined as: <!-- --> 1. HIV antibody positive; 2. Anti-HCV antibody and positive for HCV RNA; 3. HBsAg positive and HBV DNA ≥1000 cps/ml (or 200 IU/ml); i. current malignancy, or a history of malignancy. 2. need for concurrent cardiac or non-cardiac interventional or surgical procedures other than CABG (e.g., valve surgery, ventricular wall tumor surgery, peripheral arterial stenting or surgery) 3. patients with prior systemic or cardiac therapy with similar nucleic acid medications 4. a known history of drug abuse or drug allergy 5. pregnant or lactating women or those who are not using effective contraception; 6. other circumstances judged by the investigator to be inappropriate, such as the investigator's judgment that the subject may be exposed to substantial safety risks, or interference with the results of the study, or lack of participation in completing this trial in accordance with the study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
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Other studies related to the condition(s) this trial covers.
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