Cardiac EdemaPhase 2NCT06949020

A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema

A Phase 2 study testing JMKX003142 Injection in people with Cardiac Edema, run by Jemincare at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Edema
What is being tested?: JMKX003142 Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteChina
Study dates: 9 Jul 2025to 26 Apr 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
Age ≥ 18 years old when signing the informed consent form;
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;
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:
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;
During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

Who cannot join

Edema caused by diseases other than heart failure；
Subjects with ventricular assist devices during screening;
Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
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);
Subjects with hypovolemia or suspected hypovolemia;
Subject cannot feel thirst or have difficulty in fluid intake during screening;

Show all 9Show fewer

During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
Administered with tolvaptan 14days before randomization ；
Pregnancy (female pregnancy test positive) or lactation period;

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study

Conditions: Cardiac Edema
Being tested: JMKX003142 Injection, JMKX003142 placebo
Keywords: fluid retention, heart failure
Medical subject headings: Edema, Cardiac, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JMKX003142 InjectionDrug
JMKX003142 injection for experimental groups once daily for five days.
JMKX003142 InjectionDrug
JMKX003142 injection for experimental groups once daily for five days.
JMKX003142 InjectionDrug
JMKX003142 injection for experimental groups once daily for five days.
JMKX003142 placeboDrug
JMKX003142 placebo for placebo groups once daily for five days.

Study groups in NCT06949020
Study group	Role	What they receive
low dose group	Experimental	Not described Receives: Drug: JMKX003142 Injection
median dose group	Experimental	Not described Receives: Drug: JMKX003142 Injection
high dose group	Experimental	Not described Receives: Drug: JMKX003142 Injection
placebo group	Placebo comparator	Not described Receives: Drug: JMKX003142 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

body weight
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 202526 Apr 2026

First posted29 Apr 2025
Study start9 Jul 2025
Primary completion14 Mar 2026
Study completion26 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac EdemaStudies of the same condition, open and under way.
More trials run by JemincareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06949020
Sponsor's protocol ID: JMKX003142-H201
Status last verified: Aug 2026
First submitted: 22 Apr 2025
Last updated: 6 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)

All Cardiac Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study
ClinicalTrials.gov ID: NCT06949020
Acronym / sponsor ID: JMKX003142-H201
Conditions: Cardiac Edema
Keywords: fluid retention, heart failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: JemincareIndustry (pharma, biotech, devices)
Study start: 9 Jul 2025 (actual)
Primary completion: 14 Mar 2026 (actual)
Study completion: 26 Apr 2026 (actual)
First posted: 29 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
low dose group	Experimental	Drug: JMKX003142 Injection
median dose group	Experimental	Drug: JMKX003142 Injection
high dose group	Experimental	Drug: JMKX003142 Injection
placebo group	Placebo comparator	Drug: JMKX003142 placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
Age ≥ 18 years old when signing the informed consent form;
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;
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.

Key exclusion criteria (9 listed)

Edema caused by diseases other than heart failure；
Subjects with ventricular assist devices during screening;
Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
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);
Subjects with hypovolemia or suspected hypovolemia;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JMKX003142 InjectionJMKX003142 injection for experimental groups once daily for five days.	Drug	high dose group
JMKX003142 InjectionJMKX003142 injection for experimental groups once daily for five days.	Drug	low dose group
JMKX003142 InjectionJMKX003142 injection for experimental groups once daily for five days.	Drug	median dose group
JMKX003142 placeboJMKX003142 placebo for placebo groups once daily for five days.	Drug	placebo group

Primary outcome

body weight
Time frame: 5 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Cardiac Edema

Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JMKX003142 Injection in people with Cardiac Edema, run by Jemincare at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06949020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.