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

NCT06196177 | Unknown Phase 4

• 1 other identifier: KYLL-202309-008
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction （one month after TAVR）

  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 Outcomes (7)

• Left ventricular size

  one month

• left ventricular wall thickness

  one month

• NT-proBNP

  one month

• Left ventricular global long axis strain

  one month

• aortic valve orifice area

  one month

Study Arms (2)

Levosimontane group

EXPERIMENTAL

name：Levosimendan injection dose：12.5mg；once；24h

Drug: Levosimontane injection

control group

NO INTERVENTION

blank control

Interventions

Levosimontane injection DRUG

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.

Also known as: wen，yue

Levosimontane group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

QIlu hospital of shandong university

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (3)

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

• Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

  PMID: 16980116 RESULT

• Jorgensen K, Bech-Hanssen O, Houltz E, Ricksten SE. Effects of levosimendan on left ventricular relaxation and early filling at maintained preload and afterload conditions after aortic valve replacement for aortic stenosis. Circulation. 2008 Feb 26;117(8):1075-81. doi: 10.1161/CIRCULATIONAHA.107.722868. Epub 2008 Feb 11.

  PMID: 18268152 RESULT

MeSH Terms

Conditions

Heart Failure; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• guipeng an, M.D.

  Qilu hospital of Shan Dong University

  STUDY DIRECTOR

Central Study Contacts

guipeng an, M.D.

CONTACT

18560086587; guipengan@hotmail.com

zeyuan mei, bachelor

CONTACT

15662690509; 1124561015@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 9, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)