Safety and efficacy of sacubitril/valsartan for systemic right ventricular dysfunction – a prospective observational study

It is a prospective interventional study to analyse the safety and efficacy of sacubitril/valsartan in patients with systemic right ventricular dysfunction, over a therapy period of 18 months. All patients, meeting the inclusion criteria, will be recruited by the principal investigator, from the cardiology outpatient department. Patients on irregular follow up would be traced from the EMR and contacted. The investigating cardiologist will educate the patient regarding the proposed study. A consent form, written either in English or in Malayalam language, will be signed by the patient and witness of the patient (as per the SCTIMST norms). Patients who have died subsequently would be identified by records maintained in the Medical Records Department with the help of the medical social worker in the department.Treatment naïve patients would be initiated on sacubitril/valsartan at a dose of 24/26mg (1.6mg/kg/dose) twice daily. Those patients receiving 80mg of valsartan twice daily or an equivalent dose of other ACEi/ARB, would be started on sacubitril/ valsartan 49/51mg twice daily. If the dose of ACEi/ARB is less than valsartan 80mg twice daily or an equivalent dose of other ACEi/ARB, sacubitril/valsartan 24/26mg twice daily would be initiated. In children, receiving enalapril 0.1 mg/kg/dose or 0.2 mg/kg/dose would be initiated on sacubitril/valsartan 1.6 mg/kg/dose or 3.1 mg/kg/dose, respectively (maximum 200mg twice daily irrespective of body weight). Sacubitril/valsartan would be initiated after discontinuing ACEi/ARB for 36 hours. If the medication is well tolerated, sacubitril/ valsartan would be increased in a stepwise fashion until the highest tolerated dose (200mg twice daily or 3.1mg/kg/dose twice daily, whichever is lower) is reached. If systolic blood pressure < 90mmHg or <5th centile for age and height (whichever is lower), potassium

5.5mmol/L and/or eGFR <30ml/min/1.73m2 , dose would be reduced and followed-up after 2–4 weeks. Patient would be followed up at 1, 3, 6, 12, 18 months. NYHA functional class, vitals, physical examination, ECHO (2D and strain imaging), 6minute walk test, would be performed by principal investigator at baseline and each visit there after. Renal function test, serum electrolytes and NT-pro BNP test will be performed as per department protocol on follow up of heart failure patients on ACEi/ARB/ARNI. No additional invasive investigations are being planned as part of the study.