Study on the Use of Landiolol Hydrochloride and Sodium Chloride for Patients Undergoing Mitral Valve Surgery to Prevent Low-Cardiac Output Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of a medication called landiolol hydrochloride in patients undergoing surgery for the mitral valve, which is a valve in the heart. The trial aims to see if this medication can help reduce the chances of developing a condition known as Low-Cardiac Output Syndrome (LCOS) after surgery. LCOS is a situation where the heart does not pump enough blood to meet the body’s needs, which can happen after heart surgery.

In this study, participants will receive either the medication Landiobloc, which contains landiolol hydrochloride, or a placebo. Landiolol hydrochloride is a type of medication known as a beta-blocker, which helps to slow down the heart rate and reduce the heart’s workload. The study will also use a solution called sodium chloride, commonly known as saline, which is often used in medical settings to provide fluids and electrolytes.

The purpose of the study is to determine if landiolol hydrochloride can effectively reduce the occurrence of LCOS after mitral valve surgery. Participants will be randomly assigned to receive either the medication or a placebo during their surgery. The study will monitor the participants’ heart function and recovery after surgery to assess the effects of the treatment. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results.

1 joining the study

Participation begins after signing an informed consent form, confirming understanding and agreement to the trial’s terms.

Eligibility is confirmed based on criteria such as age over 18, undergoing specific mitral valve surgery, and certain heart measurements.

2 pre-surgery preparation

Preparation for elective mitral valve repair or replacement surgery is conducted.

The surgery involves a planned cardiopulmonary bypass, which is a technique that temporarily takes over the function of the heart and lungs during surgery.

3 administration of study medication

During surgery, a medication called landiolol hydrochloride is administered as an adjuvant to cardioplegia, which is a method used to protect the heart during surgery.

The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream.

4 post-surgery monitoring

After surgery, monitoring for low-cardiac output syndrome (LCOS) is conducted. This condition involves the heart not pumping enough blood to meet the body’s needs.

The primary goal is to reduce the occurrence of LCOS, which may require prolonged catecholamine infusion, mechanical assist devices, or renal replacement therapy.

5 follow-up assessments

Secondary outcomes include monitoring for prolonged catecholamine infusion, increased cardiac biomarkers, changes in heart function, hospital readmissions, and overall health status using the EQ-5D-5L questionnaire.

The trial also tracks any occurrences of death related to the condition.

Who Can Join the Study?

  • Must be older than 18 years.
  • Must be undergoing elective mitral valve repair or replacement surgery. This means the surgery is planned in advance and is not an emergency.
  • The surgery must involve a planned cardiopulmonary bypass. This is a machine that takes over the function of the heart and lungs during surgery.
  • The surgery must be done through a midline sternotomy or minithoracotomy. These are types of surgical approaches to access the heart.
  • Must have preoperative evidence of certain heart measurements:
    • Left ventricular end-systolic diameter greater than 40 mm. This is a measurement of the heart’s left ventricle size when it is contracted.
    • Left ventricular end-diastolic diameter greater than 60 mm. This is a measurement of the heart’s left ventricle size when it is relaxed.
    • Left ventricular ejection fraction less than 60%. This is a measure of how well the heart is pumping blood.
  • Must have signed informed consent. This means you agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
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Ajkzvji Ouuevmjlkwg Uxlnpvtbzvbmu Oogcguyd Renyprw Foggia Italy
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Utwkeasinj Ddmws Sncuy Dg Bawvein Brescia Italy
Ajcrfnc Sznut Snoxuamjp Tkofxzrigqvq Dnr Snkcc Lojei Varese Italy
Agsnjyg Okhwciizkxl Uufogxehvagmn Pcatnm Pisa Italy
Obgsmeqa Vmfq Fhmwc Llsaz Lecce Italy
Akrhkwy Ouvhgtguiux Roxtfnbvr Srg Cxtni Potenza Italy
Aruorcl Oogbkbwcsthqqkrxuxrsbckzr Porjwiomexw Gd Rikqwrcwcjmf Mpghj De Csasvia Catania Italy
Mvkxe Cfiviin Hrjucuzn Sdmvcz Cotignola Italy
Ccaz Dh Cfte Sco Mihlbim Snw Maddaloni, Caserta Italy
Mzjvh Dhr Hhnjrcpf Maddaloni, Caserta Italy
Ifexy Pubfldvseqs Sbd Dxlume San Donato Milanese Italy
Uvjxnlpapetcnnker Cuwmol Btbcqchywh Dx Ragk Rome Italy
Ajgzmuidlm Mndsndn Hvmgursn Lecco Italy
Atizzkb Ogidvdnhhka Nobixbjol Sy Acnwrxj E Bmgxcy E C Ayqmol Auktxukijnt Alexandria Italy
Cvbype Cajzwbviszpr Mzvspxq Saqyqw Milan Italy
Adhhlow Ofjuxoojhrvomohphohdtjtnv Szff Acabq Rome Italy
Cjbtal Ryfrmpoh Clbrcmfh Dp Vktajz Sgpulk Verona Italy
Fuvqqobnkr Tdgvtba Gxhcevhb Mkjuhdzevx Pisa Italy
Sik Cgdkskg Ftegtaddf Hkddntru Rome Italy
Asfazoc Oxbxgyfmgws Ummnckchzricm Pmzhfyiqvhv Pxklu Gillwldm Palermo Italy
Uflzvxifub Maxqd Gsgkium Ou Csfktefep Catanzaro Italy
Asgpcme Unmyc Ldzyek Swyke Sfbgolzoq N 8 Bssfsj Vicenza Italy
Azvphag Otiyoisfaqn Opotby Mkckusbsjr Dj Tecoti Turin Italy
Abagvao Onlhxxidcdb Uvwbtmpuxprcd Syj Gvdqtvhj Dx Djz E Rgavv djibryfzrmliqrt Salerno Italy
Aromkcs Scbhu Sdpjsrlmm Twoboxzxetwb Owrzo Mvgmstaa Legnano Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
31.08.2024

Trial locations

Landiolol is a medication being studied in this trial. It is used as an adjuvant, which means it is added to enhance the effect of another treatment. In this case, landiolol is used during mitral valve surgery to help protect the heart. The goal is to see if it can reduce the chances of developing a condition called low-cardiac output syndrome after surgery. This condition occurs when the heart doesn’t pump enough blood to meet the body’s needs, and the study is investigating whether landiolol can help prevent this from happening.

Low-cardiac output syndrome – This condition occurs when the heart is unable to pump enough blood to meet the body’s needs, often following cardiac surgery. It can lead to symptoms such as fatigue, shortness of breath, and reduced exercise tolerance. The syndrome may develop due to weakened heart muscle, valve problems, or complications from surgery. Patients may require medications to support heart function or mechanical devices to assist circulation. The condition is typically monitored in a hospital setting, especially in intensive care units. It is important to manage this syndrome promptly to prevent further complications.

Trial ID:
2024-515934-34-00
Protocol code:
LUNA
Trial Phase:
Therapeutic confirmatory (Phase III)

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