Sacubitril/Valsartan Versus Valsartan in Heart Failure

Damanhour University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure

Interventions

Sacubitril / Valsartan Oral TabletDRUG

Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.

Valsartan 80 mgDRUG

group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University Hospital

Tanta, Elgarbia, Egypt

Outcomes

Primary Outcomes

LVEF %

left ventricular ejection fraction percent

Time frame: 6 months

Lipo A (pg/ml)

Lipo protien A (pg/ml)

Time frame: 6 months

Troponin.I (ng/ml)

Troponin.I (ng/ml) biomarker

Time frame: 6 months

NT-Pro BNP

NT-pro BNP(pg/ml) biomarker

Time frame: 6 months

Neopterin (nmol/l)

Neopterin biomarker

Time frame: 6 Months

Data from ClinicalTrials.gov

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