NCT02294292|Completed
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Sponsor study identifier
interventional
189
1 country
1
Study Start
July 1, 2014
Actual (reported)Primary Completion
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2014
Actual (reported)July 1, 2014
Actual (reported)November 19, 2014
Actual (reported)August 31, 2016
Actual (reported)August 31, 2016
Actual (reported)Progression of cirrhosis and its complications.
1 Year
Improvement in left ventricular diastolic function in either arm.
1 Year
Renal function
1 Year
Serum level of Brain Natriuretic Peptide.
1 Year
Mortality
1 Year
Quality of life
1 Year
Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\> 90 mmHg. if carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction
Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\> 90 mmHg.
Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\> 90 mmHg. If carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Premkumar M, Rangegowda D, Vyas T, Khumuckham JS, Shasthry SM, Thomas SS, Goyal R, Kumar G, Sarin SK. Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis. J Clin Gastroenterol. 2020 Jul;54(6):561-568. doi: 10.1097/MCG.0000000000001219.
189 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2014
First Posted
November 19, 2014
Study Start
July 1, 2014
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)Last Updated
February 8, 2018
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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