Heart FailureNCT06205758
Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
An observational study of Heart Failure and Levosimendan, run by Yi Han at 1 site in China.
Trial summary
1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction; 2. Predictive modeling of the efficacy and safety of levosimendan and milrinone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Levosimendan, Milrinone
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to 1 Jun 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute heart failure (AHF), including new-onset acute heart failure AHF and acute decompensated chronic heart failure (ADHF), is usually associated with either mild or severe renal impairment. Deterioration of renal function can lead to a serious prognosis. Milrinone and levosimendan are the most commonly prescribed inotropic drugs with preclinical and clinical evidence of their renoprotective effects.
Who may be able to join
- 18-80 years old
- Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) < 50 %, and were judged by the physician to need and agree to use levosimendan or milrinone to maintain hemodynamic stability
Who cannot join
- chronic heart failure and New York Heart Association ( NYHA ) class I ~ II
- Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl < 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan
- Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan
- During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue
- received positive inotropic drug 2 treatment in the last 30 days
- Lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
Jinan, Shandong, 250014
Yi Han, doctorate, 15552565120, 15552565120@163.com
About this study
- To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction;
- Predictive modeling of the efficacy and safety of levosimendan and milrinone.
Read the detailed description
By comparing the safety and efficacy of milrinone with levosimendan as an initial inotropic agent for the treatment of patients with acute heart failure with or without abnormal renal function, a preliminary efficacy and safety prediction model was developed for levosimendan and milrinone based on the basic characteristics of the patients and the level of renal function.
- Conditions
- Heart Failure, Levosimendan, Milrinone, Efficacy, Safety
- Keywords
- Acute and advanced heart failure, Milrinone, Levosimendan, renal insufficiency
- Medical subject headings
- Heart Failure, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse outcome events
Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start16 Nov 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Han
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital
- Responsible party
- Sponsor-investigator, Yi Han, Qianfoshan Hospital
- Investigators
- Yi Han, doctorate, Principal investigator, First Affiliated Hospital of Shandon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205758
- Sponsor's protocol ID
- LM001
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
- ClinicalTrials.gov ID
- NCT06205758
- Acronym / sponsor ID
- LM001
- Conditions
- Heart Failure, Levosimendan, Milrinone, Efficacy, Safety
- Keywords
- Acute and advanced heart failure, Milrinone, Levosimendan, renal insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Yi HanUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Jan 2024 (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.
- To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction;
- Predictive modeling of the efficacy and safety of levosimendan and milrinone.
Detailed description
By comparing the safety and efficacy of milrinone with levosimendan as an initial inotropic agent for the treatment of patients with acute heart failure with or without abnormal renal function, a preliminary efficacy and safety prediction model was developed for levosimendan and milrinone based on the basic characteristics of the patients and the level of renal function.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute heart failure (AHF), including new-onset acute heart failure AHF and acute decompensated chronic heart failure (ADHF), is usually associated with either mild or severe renal impairment. Deterioration of renal function can lead to a serious prognosis. Milrinone and levosimendan are the most commonly prescribed inotropic drugs with preclinical and clinical evidence of their renoprotective effects.
Key inclusion criteria (2 listed)
- 18-80 years old
- Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) < 50 %, and were judged by the physician to need and agree to use levosimendan or milrinone to maintain hemodynamic stability
Key exclusion criteria (7 listed)
- chronic heart failure and New York Heart Association ( NYHA ) class I ~ II
- Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl < 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan
- Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan
- During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue
- received positive inotropic drug 2 treatment in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse outcome events
Time frame: 30-days
Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Yi Han, doctorate principal investigator
First Affiliated Hospital of Shandon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Levosimendan, run by Yi Han 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Han, doctorate (15552565120, 15552565120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse outcome events (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2024.