Heart FailureNCT05913271
Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
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 in the treatment of heart failure ; 2. Guide patients to apply levosimendan individually and establish a dose adjustment program. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Levosimendan, Efficacy
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 30 May 2025
- How long will I take part?
- 35 Days
- 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: Severe heart failure generally refers to the low perfusion of tissues and organs caused by acute heart failure and acute exacerbation of chronic cardiac insufficiency, which seriously affects life. It is often combined with multiple organs, especially renal function injury. Its prognosis is poor, mortality and readmission rate are high, and the 1-year mortality rate can reach more than 20 %.
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 to maintain hemodynamic stability
- Sign informed consent
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 in the treatment of heart failure ;
- Guide patients to apply levosimendan individually and establish a dose adjustment program.
Read the detailed description
The efficacy and safety of levosimendan in Chinese patients with different acetylmetabolites and CrCl(Creatine clreance) were re-evaluated after marketing. The population pharmacokinetics of different populations was studied, and the patients were guided to apply levosimendan individually and establish a dose adjustment program.
- Conditions
- Heart Failure, Levosimendan, Efficacy, Safety
- Keywords
- Severe Heart Failure, Levosimendan, NAT2(N-acetyltransferase2) Gene Polymorphism, CrCl(Creatine clreance)
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
35-day survival rate
Survival of patients at 35 days
Measured: 35-day
Secondary outcomes (3)
The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment.
Measurement of BNP（brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide）
Measured: 35-day
The improvement rate of patients ' health status
EQ-5D scale(EuroQol Five Dimensions Questionnaire) was used to assess health status
Measured: 35-day
The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue.
Incidence of composite endpoint events within 35 days
Measured: 35-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 May 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 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
- 352 participants (estimated)
- Target duration
- 35 Days
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 Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913271
- Sponsor's protocol ID
- LNAT
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
- ClinicalTrials.gov ID
- NCT05913271
- Acronym / sponsor ID
- LNAT
- Conditions
- Heart Failure, Levosimendan, Efficacy, Safety
- Keywords
- Severe Heart Failure, Levosimendan, NAT2(N-acetyltransferase2) Gene Polymorphism, CrCl(Creatine clreance)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Yi HanUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 22 Jun 2023 (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 in the treatment of heart failure ;
- Guide patients to apply levosimendan individually and establish a dose adjustment program.
Detailed description
The efficacy and safety of levosimendan in Chinese patients with different acetylmetabolites and CrCl(Creatine clreance) were re-evaluated after marketing. The population pharmacokinetics of different populations was studied, and the patients were guided to apply levosimendan individually and establish a dose adjustment program.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 35 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe heart failure generally refers to the low perfusion of tissues and organs caused by acute heart failure and acute exacerbation of chronic cardiac insufficiency, which seriously affects life. It is often combined with multiple organs, especially renal function injury. Its prognosis is poor, mortality and readmission rate are high, and the 1-year mortality rate can reach more than 20 %.
Key inclusion criteria (3 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 to maintain hemodynamic stability
- Sign informed consent
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
35-day survival rate
Time frame: 35-day
Survival of patients at 35 days
3 secondary outcomes
The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment.
Time frame: 35-day
The improvement rate of patients ' health status
Time frame: 35-day
The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue.
Time frame: 35-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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 Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
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 3 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 22 Jun 2023. 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?
35-day survival rate (time frame: 35-day). 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 22 Jun 2023.