BridgeMD
LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction
EU CTIS ID: 2024-516167-86-00
What this study is testing
To demonstrate the superiority of preoperative levosimendan vs. placebo in preventing post-operative low cardiac output syndrome in patients referred to cardiac surgery for correcting moderate to severe functional tricuspid regurgitation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale)
- Patient referred to cardiac surgery for correcting severe to moderate functional tricuspid regurgitation
- Severe tricuspid regurgitation was defined (one item required) : a. or an effective regurgitant orifice (ERO)>20mm², b. or vena contracta width >7mm, c. or systolic hepatic vein flow blunting or reserval.
You likely can't join if
- Severe hypotension defined by systolic blood pressure <90mmHg
- Left ventricular obstruction
- Allergy to levosimedan
- Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Pregnant or breastfeeding women
- Females of childbearing potential without effective method of birth control
See the full eligibility criteria
- Age ≥ 18 years
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale)
- Patient referred to cardiac surgery for correcting severe to moderate functional tricuspid regurgitation
- Severe tricuspid regurgitation was defined (one item required) : a. or an effective regurgitant orifice (ERO)>20mm², b. or vena contracta width >7mm, c. or systolic hepatic vein flow blunting or reserval.
- Severe hypotension defined by systolic blood pressure <90mmHg
- Left ventricular obstruction
- Allergy to levosimedan
- Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Pregnant or breastfeeding women
- Females of childbearing potential without effective method of birth control
- Patient on AME (state medical aid) unless exemption from affiliation
- Patient under guardianship (under “tutelle or curatelle or sauvegarde de justice or mandat de protection futur activé ou habilitation familiale” according to French law
- Severe tachycardia (>150/bpm)
- History of torsade de pointe
- Organic renal failure defined by creatinine clearance <30mL/min
- Recent endocarditis (<3 months)
- Recent myocardial infarction (<3 months)
- Tricuspid valve perforation or prolapse
- Cardiogenic shock requiring dobutamine support or cardiac assistance
- Severe liver injury (CHILD C)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.