Using Ivabradine to Treat Heart Issues in Patients with Liver Cirrhosis
Efficacy of Carvedilol + Ivabradine vs Carvedilol Alone for Left Ventricular Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality; a Prospective Randomized Controlled Trial.
This study is testing if adding ivabradine to carvedilol can help people with liver cirrhosis and heart issues feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pgimer |
| Locations | 1 site (Chandigarh, Choose Any State/Province) |
| Trial ID | NCT04111133 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 130 patients with liver cirrhosis who have been diagnosed with left ventricular diastolic dysfunction. Participants will be randomly assigned to receive either a combination of carvedilol and ivabradine or carvedilol alone, with the goal of reducing heart rate to improve cardiac function. The study will evaluate the effectiveness of ivabradine, particularly for patients who cannot tolerate beta-blockers due to side effects. Assessments will occur at baseline, 6 months, and 12 months to monitor clinical events, cardiac and renal function, and mortality rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with liver cirrhosis and diagnosed left ventricular diastolic dysfunction.
Not a fit: Patients with chronic renal disease, existing beta-blocker therapy, or other significant cardiac or systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with cirrhotic cardiomyopathy who cannot tolerate standard beta-blocker therapy.
How similar studies have performed: Previous studies have shown promise in using targeted heart rate reduction for managing left ventricular diastolic dysfunction in cirrhosis, but the specific use of ivabradine alone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range of 18-65 years * Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings, * LV diastolic dysfunction on 2D echocardiography Exclusion Criteria: * Chronic renal disease * Patient already on beta blocker * 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
Where this trial is running
Chandigarh, Choose Any State/Province
- Postgraduate Institute of Medical Education and Research — Chandigarh, Choose Any State/Province, India (Recruiting)
Study contacts
- Study coordinator: Madhumita Premkumar, MD DM
- Email: drmadhumitap@gmail.com
- Phone: 01722756344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.