Sacubitril/Valsartan Versus Valsartan in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-19

Brief Summary

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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double Blind randomized controlled trial

Study Groups

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Group 1 (N = 40)

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

Group Type EXPERIMENTAL

Sacubitril / Valsartan Oral Tablet

Intervention Type DRUG

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

Group 2 (N = 40)

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

Group Type EXPERIMENTAL

Valsartan 80 mg

Intervention Type DRUG

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

Interventions

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Sacubitril / Valsartan Oral Tablet

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

Intervention Type DRUG

Valsartan 80 mg

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

Intervention Type DRUG

Other Intervention Names

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sacubitril / valsartan (100 mg twice daily) Valsartan

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No