Echocardiographic and Biochemical Outcomes of Right Heart Dysfunction In Patients Undergoing Valve Replacement Surgery for Stenotic Lesions of the Mitral Valve A Therapeutic Comparison of Milrinone Vs Levosimendan

Echocardiographic and Biochemical Outcomes of Right Heart Dysfunction In Patients Undergoing Valve Replacement Surgery for Stenotic Lesions of the Mitral Valve A Therapeutic Comparison of Milrinone Vs Levosimendan - ECHOBIOM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109875

Enrollment

Registered

2026-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I272- Other secondary pulmonary hypertension

Interventions

Intervention1: Inj. Levosimendan: Inj. Levosimendan 12 mcg/kg over 10 minutes after induction followed by 0.1 mcg/kg/min intraoperatively Intervention2: Inj. Milrinone: Inj. Milrinone 50 mcg/kg over 1

Eligibility

Inclusion criteria

Inclusion criteria: i. Inclusion Criteria 1. Adult male/female aged 40-65 years 2. Patients with mitral valve stenosis undergoing elective mitral valve replacement surgery under general anaesthesia under cardiopulmonary bypass

Exclusion criteria

Exclusion criteria: ii. Exclusion Criteria 1. Patient s refusal 2. Known allergy to any of the study drugs 3. NYHA Grade 4 4. Presence of haemodynamically significant arrhythmia 5. Presence of hepatic / renal disease 6. Presence of significant coronary artery disease

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Milrinone versus Levosimendan in maintaining right ventricular-pulmonary arterial (RV-PA) coupling in patients undergoing mitral valve replacement for mitral stenosis.Timepoint: T0 Preoperative Biochemical tests and TTE T1- After induction Start test drug infusions, collection of blood sample for biochemical analysis, Baseline TEE. T2 After cannulation and initiation of CPB ACT, MvO2, TEE to check cannula position. T3- during cardiopulmonary bypass - MvO2, ABG, ACT T4 - after rewarming and weaning from cardiopulmonary bypass prior to sternal closure. Post procedure TEE for cardiac and prosthesis function, Temperature, ACT, ABG, Lactate, MvO2. T5, T6, T7 T8 study points are 1 hr, 6hr, 12 hr of ICU stay respectively ABG, Lactate T9 & T10 : 24 hours & 48 hours : TTE to measure RV Function and global function including volume status, ABG, Lactate, Serum Urea, creatinine, N-Terminal Pro Brain Natriuretic peptide (NT-ProBNP), Serum Cortisol, Serum Insulin Like Growth Factor(IGF), Lactate Dehydrogenase, Lipid Profile, Inflammatory markers like CRP (at time points Preop, 24 and 48 hour postop). T11 30 days from surgery, T12 60 days from surgery. Physical status, 2D TTE	—

Measure

Time frame

To compare the efficacy of Milrinone versus Levosimendan in maintaining right ventricular-pulmonary arterial (RV-PA) coupling in patients undergoing mitral valve replacement for mitral stenosis.Timepoint: T0 Preoperative Biochemical tests and TTE T1- After induction Start test drug infusions, collection of blood sample for biochemical analysis, Baseline TEE. T2 After cannulation and initiation of CPB ACT, MvO2, TEE to check cannula position. T3- during cardiopulmonary bypass - MvO2, ABG, ACT T4 - after rewarming and weaning from cardiopulmonary bypass prior to sternal closure. Post procedure TEE for cardiac and prosthesis function, Temperature, ACT, ABG, Lactate, MvO2. T5, T6, T7 T8 study points are 1 hr, 6hr, 12 hr of ICU stay respectively ABG, Lactate T9 & T10 : 24 hours & 48 hours : TTE to measure RV Function and global function including volume status, ABG, Lactate, Serum Urea, creatinine, N-Terminal Pro Brain Natriuretic peptide (NT-ProBNP), Serum Cortisol, Serum Insulin Like Growth Factor(IGF), Lactate Dehydrogenase, Lipid Profile, Inflammatory markers like CRP (at time points Preop, 24 and 48 hour postop). T11 30 days from surgery, T12 60 days from surgery. Physical status, 2D TTE

—

Secondary

Measure	Time frame
To compare the change in echocardiographic parameters in Group M (Patients receiving Milrinone) vs Group L (patients receiving Levosimendan)Timepoint: T0, T1,T4,T9, T10,T11,T12;To compare the change in biochemical parameters in Group M (Patients receiving Milrinone) vs Group L (patients receiving Levosimendan)Timepoint: T0,T1,T09,T10;To compare the outcome based on preoperative Predicting Risk of cardiovascular disease EVENTs (PREVENTTM) scoreTimepoint: T0, T11,T12;To compare immediate post operative, 30-day, 60-day outcomes of the patients including functional statusTimepoint: T11,T12	—

Measure

Time frame

To compare the change in echocardiographic parameters in Group M (Patients receiving Milrinone) vs Group L (patients receiving Levosimendan)Timepoint: T0, T1,T4,T9, T10,T11,T12;To compare the change in biochemical parameters in Group M (Patients receiving Milrinone) vs Group L (patients receiving Levosimendan)Timepoint: T0,T1,T09,T10;To compare the outcome based on preoperative Predicting Risk of cardiovascular disease EVENTs (PREVENTTM) scoreTimepoint: T0, T11,T12;To compare immediate post operative, 30-day, 60-day outcomes of the patients including functional statusTimepoint: T11,T12

—

Countries

India

Contacts

Public ContactAnmol SIngh

IPGME&R SSKM Kolkata

dranmolsinghchd@gmail.com9814019104

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026