A Phase 4 interventional study of Empagliflozin + Carvedilol and Carvedilol in Cirrhotic Cardiomyopathy, Empagliflozin and Cardiometabolic Risk Factors, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 4, Interventional, and Treatment
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.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 400 is above the median of 63 across 840 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.
Compared within Fibrosis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: Empagliflozin + Carvedilol-arm * Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes for 1 year from randomization * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate * Standard Medical Therapy for liver disease as per clinician decision
Drug: Empagliflozin + Carvedilol
* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo administered once daily. * Standard Medical Therapy prescribed as per clinician decision
Drug: Carvedilol
Drug pages: Empagliflozin · Carvedilol
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.
* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo pill * Standard Medical Therapy
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
Time frame: 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 Septal E/e' ratio
Time frame: 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 Septal e' velocity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrolment through study completion, an average of 1 year
Hospitalization events
• Episodes warranting hospitalization
Time frame: From enrolment through study completion, an average of 1 year
• Serum level of NT-proBNP
Cardiac biomarkers
Time frame: At enrolment
• Serum level of NT-proBNP
Cardiac biomarkers
Time frame: At 6 months from enrolment
• Serum level of NT-proBNP
Cardiac biomarkers
Time frame: At 12 months from enrolment
• Serum level of Galectin-3
Cardiac biomarkers
Time frame: At enrolment
• Serum level of Galectin 3
Cardiac biomarkers
Time frame: At 6 months from enrolment
• Serum level of Galectin 3
Cardiac biomarkers
Time frame: At 12 months from enrolment
• Serum level of Aldosterone
Cardiac biomarkers
Time frame: At enrolment
• Serum level of Aldosterone
Cardiac biomarkers- Renin angiotensin aldosterone system
Time frame: At 6 months from enrolment
• Serum level of Aldosterone
Cardiac biomarkers- Renin angiotensin aldosterone system
Time frame: At 12 months from enrolment
Plan to share: No — This database has identifier information
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Started Apr 2026 (actual). Primary completion is estimated for Jan 2029, 33 months after the start.
Of 38 non-industry phase 4 interventional studies under Fibrosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 33 months is close to that.
Counting every sponsor, half of 41 studies reached it within 37 months; a quarter within 21 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Empagliflozin · Carvedilol
Post Graduate Institute of Medical Education and Research, Chandigarh →