Sacubitril/Valsartan Versus Valsartan in Heart Failure

Study Overview
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Brief Summary
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The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.

Detailed Description
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Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.

Official Title
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Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Sacubitril / Valsartan Oral Tablet
* Drug: Valsartan 80 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with HF were enrolled if aged > 35 years, Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%, NYHA class II-III, Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy. Exclusion Criteria: Patients with acute decompensation, Cerebrovascular events during the previous 6 months, Pregnancy, breastfeeding, Any valve dysfunction/abnormality, Active myocarditis, Second-degree and third-degree atrioventricular block, Sick sinus syndrome.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 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
Interventional Model Description: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (N = 40)<br>Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment. | Drug: Sacubitril / Valsartan Oral Tablet<br>* Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.<br>* Other names: sacubitril / valsartan (100 mg twice daily);|
| Experimental: Group 2 (N = 40)<br>group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. | Drug: Valsartan 80 mg<br>* group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.<br>* Other names: Valsartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF % | left ventricular ejection fraction percent | 6 months | 
| Lipo A (pg/ml) | Lipo protien A (pg/ml) | 6 months | 
| Troponin.I (ng/ml) | Troponin.I (ng/ml) biomarker | 6 months | 
| NT-Pro BNP | NT-pro BNP(pg/ml) biomarker | 6 months | 
| Neopterin (nmol/l) | Neopterin biomarker | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVEF%,, Lipo A,, troponin I,, NT-Pro BNP,, neopterin