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New diagnostic criteria for cirrhotic cardiomyopathy For the diagnosis of cirrhotic cardiomyopathy (CCM) we will use criteria proposed by the CCM consortium in 2020 with modification to take septal e' and E/e' readings. In accordance with the recent CCM criteria 'systolic dysfunction is defined as an ejection fraction (EF) of 50% or less or an absolute value of GLS <18%. LVDD grade will be determined if 3 of the following 4 criteria are met: early diastolic trans mitral flow to early diastolic mitral annular velocity (E/e') ≥15 left atrial volume index (LAVI) >34 mL/m2 septal early diastolic mitral annular velocity (e') <7 cm/second or tricuspid regurgitation (TR) maximum velocity >2.8 m/second in the absence of pulmonary hypertension (HTN) and the presence of measurable early to late diastolic trans mitral flow velocity (E/A) ratio (E/A >2 = grade 3 E/A 0.8-2 = grade 2)'. LVDD will be classified as "of indeterminate grade" when only 2 of the 4 criteria are met. The supporting criteria for diagnosis of LVDD are changes in cardiac chamber sizes electrophysiological abnormalities increased biomarkers like N terminal pro-brain natriuretic peptide (NT-Pro BNP) and troponin I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Empagliflozin + Carvedilol-arm | Active Comparator | Experimental: Empagliflozin + Carvedilol-arm
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| Active Comparator: Carvedilol arm | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin + Carvedilol | Drug | Patient Recruitment: The study participants are all cirrhosis patients receiving treatment at PGIMER Chandigarh. Eligible participants meeting LVDD criteria per the CCM Consortium 2020 consensus. Carvedilol Dosing protocol in this study Patients will be given carvedilol in a starting dose of 3.125 mg twice daily. The dose will be titrated weekly to achieve a target heart rate of 50-60/ min taking care that side effects such as hypotension bronchospasm excessive bradycardia are not seen. The maximum dosage allowed as per prior trial data is 25 mg per day. Empagliflozin Dosing protocol in this Study: • All patients will receive a standard dose of Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite end point of decompensation event and/or death | The primary outcome measure is defined as a composite end point of acute decompensation event (acute variceal bleeding new ascites or recurrence of previously controlled ascites episode of hepatic encephalopathy or acute kidney injury) OR all-cause death in patients with cirrhosis and LVDD | From enrolment through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Cardiac Diastolic Function | Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging Septal E/e' ratio | From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Diastolic Function |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madhumita Premkumar, MD DM | Contact | 01722754777 | drmadhumitap@gmail.com | |
| Madumita Premkumar | Contact | 01722754777 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER Chandigarh | Recruiting | Chandigarh | 160012 | India |
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Double Blind Placebo controlled Randomized Controlled Trial
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| Carvedilol | Drug |
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Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging Septal e' velocity |
| From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Diastolic Function | Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging Left atrial volume index | From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Diastolic Function | Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging Tricuspid regurgitant Velocity | From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Systolic Function | Improvement in Cardiac systolic function (Cardiac Index) in either arm based on Echocardiography and Cardiac Imaging | From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Systolic Function | Improvement in Cardiac systolic function (Ejection Fraction) in either arm based on Echocardiography and Cardiac Imaging | From enrolment through study completion, an average of 1 year |
| Improvement in Cardiac Systolic Function | Improvement in Cardiac systolic function (Global Longitudinal Strain) in either arm based on Echocardiography and Cardiac Imaging | From enrolment through study completion, an average of 1 year |
| Hospitalization events | • Episodes warranting hospitalization | From enrolment through study completion, an average of 1 year |
| • Serum level of NT-proBNP | Cardiac biomarkers | At enrolment |
| • Serum level of NT-proBNP | Cardiac biomarkers | At 6 months from enrolment |
| • Serum level of NT-proBNP | Cardiac biomarkers | At 12 months from enrolment |
| • Serum level of Galectin-3 | Cardiac biomarkers | At enrolment |
| • Serum level of Galectin 3 | Cardiac biomarkers | At 6 months from enrolment |
| • Serum level of Galectin 3 | Cardiac biomarkers | At 12 months from enrolment |
| • Serum level of Aldosterone | Cardiac biomarkers | At enrolment |
| • Serum level of Aldosterone | Cardiac biomarkers- Renin angiotensin aldosterone system | At 6 months from enrolment |
| • Serum level of Aldosterone | Cardiac biomarkers- Renin angiotensin aldosterone system | At 12 months from enrolment |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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