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

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: Sacubitril-Valsartan; Drug: Valsartan

• Registration Number: NCT04688294
• Lead Sponsor: Amir Safwat

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Primary Completion: 2021-05-01
• Study Completion: 2021-07-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-18
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacubitril/valsartan	Sacubitril-Valsartan	Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.
Valsartan	Valsartan	Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.

Primary Outcome Measures

Name	Time	Method
change in NTproBNP plasma concentration	at 6 months	NTproBNP is a Biomarker used to assess severity of congestive heart failure)
severity of congestive heart failure.	at 6 months	Ejection fraction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wadi El-Neel Hospital; 🇪🇬 Cairo, Egypt