Can a Five-Day injection drain the fluid that weighs down heart failure patients?
NCT ID NCT06949020
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests an experimental injection called JMKX003142 in people with heart failure who have fluid buildup (edema), causing swelling and congestion. Participants receive either the drug or a placebo once daily for five days. The goal is to see if the drug safely reduces excess fluid, as measured by weight loss, and to understand how it works in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JMKX003142 injection (an experimental drug given once daily for five days)
- What this could lead to
- If successful, this could lead to a new treatment to quickly relieve fluid overload in heart failure patients, improving comfort and reducing hospital stays.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Possible side effects are not yet fully known.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
160 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
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: 1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form; 2. Age ≥ 18 years old when signing the informed consent form; 3. At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion; 4. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period: 1\) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics. 5\. After the background treatment in the run-in period, the subject still has the following two conditions: 1. One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion; 2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3. Exclusion Criteria: 1. Edema caused by diseases other than heart failure; 2. Subjects with ventricular assist devices during screening; 3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening; 4. Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction); 5. Subjects with hypovolemia or suspected hypovolemia; 6. Subject cannot feel thirst or have difficulty in fluid intake during screening; 7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg; 8. Administered with tolvaptan 14days before randomization ; 9. Pregnancy (female pregnancy test positive) or lactation period;
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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
-
The Second Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310009, China