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

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.

1. New York Heart Association (NYHA) Class.
2. Frequency of hospitalization by acute exacerbation of CHF
3. NT-ProBNP
4. Left ventricular systolic function by Echocardiography

Moreover, the side effects of the drugs used during study was assessed by

1. Renal function (Serum creatinine) was performed every month till the end of the study.
2. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Sacubitril-Valsartan; Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Wadi El-Neel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 40 - 60 years
2. Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification
3. Left Ventricular Ejection Fraction of 40% or less.
4. NT-proBNP level of at least ≥400 pg per milliliter
5. ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.

Exclusion Criteria:

1. Patients with symptomatic hypotension.
2. Pregnant and nursing women
3. Systolic blood pressure < 100 mmHg at screening or < 95 mmHg at randomization
4. Patients with glomerular filtration rate <30 mL/min/1.73 m2
5. Patients with history of angioedema
6. Patients with unacceptable side effects with ACE-inhibitors or ARBs.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacubitril/valsartan; Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.	Drug: Sacubitril-Valsartan; 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
Active Comparator: Valsartan; Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.	Drug: Valsartan; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amir Safwat

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 18, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: 3/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No