Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients

Study Overview
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Brief Summary
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The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering

Detailed Description
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Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).

Official Title
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Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients

Conditions
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Heart Failure NYHA Class IV, Heart Failure NYHA Class II

Intervention / Treatment
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* Drug: Sacubitril / Valsartan Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart failure (NYHA class II-IV). LV EF(less than or equal to 40%). eGFR (more than 30 ml/min /1.73m2). Exclusion Criteria: Symptomatic hypotension. eGFR<30 ml/min/1.73m2 . Serum potassium >5.2mmol/L Angioedema

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Sacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan. The recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient. Reduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for: Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. Patients with severe renal impairment (CrCl less than 30 ml/min) Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient | Drug: Sacubitril / Valsartan Oral Tablet<br>* Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB.<br>* Other names: Sacvin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire | comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan | 1 year | 
| Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire | Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor | changes in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronickindeydisease, qualityoflife