An interventional study of Betablocker + ivabradine and Betablocker in Cirrhotic Cardiomyopathy, Left Ventricular Dysfunction and Cirrhosis, Liver, 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 2024-02-13.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment
A total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2D echocardiography, will then be randomized by Block randomization technique, to two arms in a ratio 1:1(Group A) will receive carvedilol+ Ivabradine targeted therapy for heart rate reduction while Group B will receive Carvedilol alone; and the dosage of drug in the treatment arm will be titrated every week to achieve target heart rate of 50-60/ minute. Patients in the treatment arms, who are unable to tolerate carvedilol due to hypotension episodes, will be offered ivabradine alone to allow achievement of targeted heart rate reduction. All patients will be evaluated at 0,6, and 12 months. The end points will be clinical events, cardiac function improvement, renal function, and mortality.
The investigators have already demonstrated the role of targeted heart rate reduction in the management of LVDD in cirrhosis, but the previous study could not demonstrate the role of ivabradine alone in absence of betablocker therapy. This trial will be a validation cohort for the initial data obtained on this novel drug. The use of ivabradine can treat patients who do not tolerate betablocker therapy due to contraindications or adverse effects especially hypotension.
Diagnosis of CCM will be as per 2020 CCMC criteria. CCM is defined as systolic or diastolic dysfunction in the absence of alternative cardiac pathology in concordance with the Cirrhotic Cardiomyopathy Consortium (CCMC) criteria. 9 Systolic dysfunction was defined as an ejection fraction (EF) ≤50% or an absolute value of GLS \<18%. CCM will defined as presence of 3 of the following 4 criteria: septal early diastolic mitral annular flow velocity (e') \<7 cm/s, early diastolic transmitral flow to early diastolic mitral annular velocity (E/e') ≥15, left atrial volume index (LAVI) >34 mL/m2, tricuspid jet maximum velocity >2.8 m/s, in the absence of pulmonary hypertension and the presence of measurable early to late diastolic transmitral flow velocity (E/A) ratio (E/A >2 = grade 3 \& E/A 0.8-2 = grade 2 LVDD). Persons meeting only 2 criteria will be termed as indeterminate for LVDD grade.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 130 is above the median of 100 across 151 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left 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.
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Exclusion Criteria:
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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).
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.
Drug: Betablocker + ivabradine
Drug: Betablocker
Use of maximum tolerated dose of carvedilol and ivabradine to achieve therapeutic heart rate reduction (THR) to 55-65 beats per minute
Use of maximum tolerated dose of carvedilol to achieve targeted heart rate reduction (THR) to 55-65 beats per minute (responder) or inability to reach THR (non responder) with maximum dose of carvedilol, maintaining a minimum MAP of 70 mmHg.
Survival
All cause mortality to be assessed
Time frame: 12 months
Change in E/e' Ratio
Echo parameter to be documented
Time frame: 12 months
Change in renal function
Time frame: 12 months
Change in HRQoL
Time frame: 12 months
Change in neurohormonal markers- Brain natriuretic peptide, aldosterone, plasma renin activity
Time frame: 12 months
Number of Episodes of Cirrhosis related events
New onset ascites, variceal bleeding,hepatorenal syndrome
Time frame: 12 months
Plan to share: Undecided
Started Jan 2020 (actual). Primary completion is estimated for Oct 2024, 57 months after the start.
Of 34 interventional studies with no phase under Ventricular Dysfunction, Left, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 86. This study's planned 57 months is above that.
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