Telmisartan Versus Enalapril in Heart Failure With Reduced Ejection Fraction Patients With Moderately Impaired Kidney Functions

Summary

Participation Requirements

Description

Population of study & disease condition Chronic heart Failure patients with reduced ejection fraction, (LVEF <40%) associated with moderate impairment of renal functions, (eGFR by Cockroft-Gold equation 60-40 ml/min/m2). Patients will be randomized to receive either Enalapril (2.5 up to 20mg ) or Te...

Population of study & disease condition Chronic heart Failure patients with reduced ejection fraction, (LVEF <40%) associated with moderate impairment of renal functions, (eGFR by Cockroft-Gold equation 60-40 ml/min/m2). Patients will be randomized to receive either Enalapril (2.5 up to 20mg ) or Telmisartan (20 up to 80mg) for RAAS inhibition, as part of their heart failure therapy. Objectives: - Compare efficacy, safety and tolerability of Telmisartan versus Enalapril in HFrEF patients with impaired renal function. • Methodology in details: HFrEF patients with moderate renal impairment as defined per protocol and after accepting participation to the study, will be randomly allocated into 2 equal groups using closed envelopes randomization system based on web-based randomization tables. Group 1 will receive Enalapril (between 2.5 to 20mg daily) as tolerated. Group 2 will receive Telmisartan (between 10 to 80mg daily) as tolerated. Both groups will receive other guidelines directed medical therapy for HFrEF. Patients will be monitored for :- Improvement of NYHA class. Six-minutes walk test at baseline at 2, 6 and 12 months. Trends of changes in NT-BNP values from baseline and every 6 months. Changes in left ventricular dimensions and ejection fraction assessed by echocardiography at baseline, at 6 and 12 months. Rates of worsening kidney functions assessed by changes in serum creatinine and in eGFR from baseline. Rates of improvement in albuminuria and serum albumin assessed by urinary Albumin/Creatinine ratio and serum albumin levels respectively, at baseline at 2, 6 and 12 months. Rates of discontinuation of / intolerance to the used agent for RAAS inhibition (enalapril/telmisartan) Rates of rehospitalization for decompensated heart failure. Rates of rehospitalization for any reason. Cardiac death. All-cause death.

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