The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate side effects of this combination. - The following parameters were determined at baseline and at end of the study at 6 months of the beginning. New York Heart Association (NYHA) Class. Frequency of hospitalization by acute exacerbation of CHF NT-ProBNP Left ventricular systolic function by Echocardiography Moreover, the side effects of the drugs used during study was assessed by Renal function (Serum creatinine) was performed every month till the end of the study. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.

Official Title
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The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Sacubitril-Valsartan
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 - 60 years Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification Left Ventricular Ejection Fraction of 40% or less. NT-proBNP level of at least ≥400 pg per milliliter ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day. Exclusion Criteria: Patients with symptomatic hypotension. Pregnant and nursing women Systolic blood pressure < 100 mmHg at screening or < 95 mmHg at randomization Patients with glomerular filtration rate <30 mL/min/1.73 m2 Patients with history of angioedema Patients with unacceptable side effects with ACE-inhibitors or ARBs.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacubitril/valsartan<br>Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy. | Drug: Sacubitril-Valsartan<br>* 30 patients initially received Sacubitril/Valsartan at 24/26 mg twice daily orally then dose was doubled as tolerated every 2-4 weeks to reach the target maintenance dose 97 mg/103 mg twice daily<br>|
| Active Comparator: Valsartan<br>Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy. | Drug: Valsartan<br>* 30 patients received valsartan, starting at a dose of 40 mg/day orally. The dose was then doubled every 1-2 weeks on the basis of their blood pressure to reach a dose of 160 mg once daily according to guideline-directed medical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in NTproBNP plasma concentration | NTproBNP is a Biomarker used to assess severity of congestive heart failure) | at baseline | 
| change in NTproBNP plasma concentration | NTproBNP is a Biomarker used to assess severity of congestive heart failure) | at 6 months | 
| severity of congestive heart failure. | Ejection fraction | at baseline | 
| severity of congestive heart failure. | Ejection fraction | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma potassium concentration | plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan | every month, up to 6 months | 
| change in serum sodium concentration | serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan | every month, up to 6 months | 
| change in serum creatinine | serum creatinine which is a byproduct of muscle protein metabolism is used to evaluate Sacubitril-Valsartan | every month, up to 6 months |