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New treatment option for Cardiac Failure
Official title Landiolol in Mitral Valve Surgery
ClinicalTrials.gov ID: NCT06793670
What this study is testing
What is Landiolol?
Landiolol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiac failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic mitral regurgitation is the most common valvular abnormality worldwide, it occurs in 10% of the general population and its prevalence increases with age. When left untreated, it can lead to left ventricular dysfunction and cause disabling symptoms (e.g., fatigue and dyspnea), life-threatening complications (e.g., ventricular dilation, congestive heart failure) and death.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Older than 18 years;
- Elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy;
- Preoperative evidence of left ventricular end-systolic diameter \>40 mm and/or left ventricular end-diastolic diameter \>60 mm and/or left...
- Signed informed consent.
You likely can't join if
- Need for preoperative dialysis;
- Hepatic dysfunction (defined as Child-Pugh class C);
- History of previous unusual response to beta-blockers;
- Urgent or emergency surgery;
- Patient already in need of mechanical circulatory support before surgery (except for IABP);
- Pregnancy as documented by a pregnancy test performed in the last 72h before surgery;
See the full eligibility criteria
- Older than 18 years;
- Elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy;
- Preoperative evidence of left ventricular end-systolic diameter \>40 mm and/or left ventricular end-diastolic diameter \>60 mm and/or left ventricular ejection fraction\<60%;
- Signed informed consent.
- Need for preoperative dialysis;
- Hepatic dysfunction (defined as Child-Pugh class C);
- History of previous unusual response to beta-blockers;
- Urgent or emergency surgery;
- Patient already in need of mechanical circulatory support before surgery (except for IABP);
- Pregnancy as documented by a pregnancy test performed in the last 72h before surgery;
- Patients with preoperative evidence of hypernatremia (serum sodium concentration: \> 160 mmol/L);
- Patients with preoperative evidence of hyperchloremia (serum chloride concentration: \>115 mmol/L);
- Patients with hypersensitivity to the active substance or to any of the excipients;
- Patients with severe bradycardia (less than 50 beats per minute) sick sinus syndrome, severe atrioventricular nodal conductance disorders or 2nd -3rd degree atrioventricular block and without a pacemaker;
- Patients with cardiogenic shock, severe hypotension (MAP\ 70 mmHg);
- Patients with non-treated phaeochromocytoma;
- Patients with acute asthmatic attack;
- Patients with severe, uncorrectable metabolic acidosis.
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- Planned use of ultra-short acting beta-blockers as intraoperative cardiac protective strategy.
- Refusal or inability to sign the informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, Piedmont, Italy
- Torino, TO, Italy
- Alessandria, Italy
- Catania, Italy
- Florence, Italy
- Foggia, Italy
- Genova, Italy
- Milan, Italy
- Palermo, Italy
- Pisa, Italy
- Potenza, Italy
- Ravenna, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Piedmont, Italy; Torino, TO, Italy; Alessandria, Italy; Catania, Italy; Florence, Italy; Foggia, Italy and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.