- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02294292
Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality
Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging.
- Age range of 18-60 years
- Cirrhosis as diagnosed by histology or clinical, laboratory and USG (UltraSonography) findings,
- Upper GI bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices
Exclusion Criteria:
- Age >60 years
- Chronic renal disease
- Pregnancy and peripartum cardiomyopathy
- Hypertension
- Coronary artery disease
- Valvular heart disease
- Sick sinus syndrome/ Pacemaker
- Cardiac rhythm disorder
- Hypothyroidism
- Hyperthyroidism
- Portal vein thrombosis
- Transjugular intrahepatic porto systemic shunt (TIPS) insertion
- Hepatocellular carcinoma
- Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Carvedilol + Ivabradine
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 |
ACTIVE_COMPARATOR: Endoscopic Variceal Ligation (EVL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression of cirrhosis and its complications.
Time Frame: 1 Year
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in left ventricular diastolic function in either arm.
Time Frame: 1 Year
|
1 Year
|
|
Renal function
Time Frame: 1 Year
|
Renal function is being checked- urea, creatinine, urine sediment, and creatinine clearance as calculated by Cockcroft - Gault formula
|
1 Year
|
Serum level of Brain Natriuretic Peptide.
Time Frame: 1 Year
|
1 Year
|
|
Mortality
Time Frame: 1 Year
|
1 Year
|
|
Quality of life
Time Frame: 1 Year
|
1 Year
|
|
Electrophysiologic modifications
Time Frame: 1 Year
|
Electrophysiological changes checked are QTc interval, documentation of arrhythmias
|
1 Year
|
Serum level of catecholamines
Time Frame: 1 year
|
1 year
|
|
Serum level of plasma renin activity
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Carvedilol
Other Study ID Numbers
- ILBS-CLD-DD-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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