Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure

April 1, 2024 updated by: Qilu Hospital of Shandong University

Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study

Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve replacement (TAVR) has brought new hope for these patients, and since its birth in 2002, TAVR has been widely used internationally, and its safety and efficacy have been confirmed by several large, prospective, randomized controlled studies.

Levosimendan is a new type of positive inotropic drug. It not only enhances myocardial contractile force through calcium sensitization, but also activates K+ sensitive channel KATP on the membrane of vascular smooth muscle, relaxes the arteries and veins of the whole body, and reduces the front and back load of the heart, pulmonary vascular resistance and systemic vascular resistance. A series of studies suggested that for patients undergoing thoracotomy in various cardiac surgeries, regardless of whether the patients were accompanied by ventricular systolic dysfunction before surgery, the use of levosimendan resulted in significantly higher postoperative cardiac function and decreased mortality than the control group, and patients with preoperative LVEF < 40% benefited more.

At present, there are no studies to clarify the regulatory effect of levosimendan on cardiac function after TAVR in patients with severe aortic stenosis complicated with cardiac insufficiency. This is a randomized controlled study. On the basis of basic drug therapy, the treatment group was given levosimendan to analyze the regulatory effect of levosimendan on cardiac function after TAVR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We plan to recruit 112 patients with severe aortic stenosis and cardiac insufficiency, which，after TAVR, were randomly divided into treatment group (56 cases, intravenous levosimendan) and control group (56 cases).

The treatment group was given levosimendan injection intravenously once: 12.5mg levosimendan injection was diluted to 50ml with 5% glucose injection, the initial pump speed was 2ml/h, and maintained for 24 hours.

In the process of drug q1h monitoring blood pressure. If the systolic blood pressure was lower than 90mmHg, the blood pressure was remeasured 5 minutes later. If the systolic blood pressure was still lower than 90mmHg, 10mg norepinephrine injection +45ml 5% glucose injection was given intravenously by micro pump, the initial 2ml/h. The blood pressure was monitored, and the pump speed was adjusted according to the blood pressure to maintain the systolic blood pressure at 90-110mmHg.

Preoperative and postoperative immediately, after 3 days and postoperative 1 month, electrocardiogram, echocardiography and venous blood. Three tubes of venous blood were collected each time, and each tube was sent to the laboratory department of Qilu Hospital for blood routine, liver and kidney function, blood biochemistry, NT-proBNP and troponin I detection. The remaining samples were destroyed immediately after detection. The results of 6-minute walk test and the incidence of cardiovascular events were recorded at 1 month after operation.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • 山东省
      • Jinan, 山东省, China, 250000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patients aged 65-85 years undergoing TAVR;
  • Echocardiography diagnosed severe aortic valve stenosis with LVEF<0.4；
  • Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form.

Exclusion Criteria:

  • Adverse reactions to levosimendan or other excipients;
  • In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases;
  • Patients with severe hepatic and renal impairment (creatinine clearance <30ml/min);
  • Patients with severe hypotension (SBP<90mmHg or DBP<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions.
  • Severe complications occurred during TAVR.
  • Are involved in other clinical studies
  • Other clinically significant respiratory, digestive, hematological, infectious, immune, endocrine, neuropsychiatric, tumor diseases, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levosimontane group
name：Levosimendan injection dose：12.5mg；once；24h
Drug: Levosimontane injection
Levosimendan injection was given once intravenously with a micro-pump: 12.5mg levosimendan injection was diluted with 5% glucose injection to 50ml at the initial pump speed of 2ml/h for 24h.
Other Names:
  • wen，yue
No Intervention: control group
blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction （one month after TAVR）
Time Frame: one month
At 1-month follow-up, left ventricular ejection fraction was measured by echocardiography in patients with severe aortic stenosis complicated with heart failure after TAVR.
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular size
Time Frame: one month
At 1 month follow-up, the change of left ventricular size before and after TAVR.
one month
left ventricular wall thickness
Time Frame: one month
At 1 month follow-up, the change of left ventricular wall thickness before and after TAVR.
one month
NT-proBNP
Time Frame: one month
At 1 month follow-up, the change of NT-proBNP before and after TAVR.
one month
Left ventricular global long axis strain
Time Frame: one month
At 1 month follow-up, the change of left ventricular global long axis strain before and after TAVR.
one month
aortic valve orifice area
Time Frame: one month
At 1 month follow-up, the change of aortic valve orifice area before and after TAVR.
one month
The result of 6-minute walking experiment
Time Frame: one month
The result of 6-minute walking experiment was analyzed 1 month after TAVR.
one month
Incidence of cardiovascular events
Time Frame: one month
The incidence of cardiovascular disease was measured 1 month after TAVR.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Director: guipeng an, M.D., Qilu hospital of Shan Dong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202309-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have no plans to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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