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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688294
• Other study ID #: 3/2019
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Wadi El-Neel Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Amir Safwat

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in NTproBNP plasma concentration	NTproBNP is a Biomarker used to assess severity of congestive heart failure)	at baseline
Primary	change in NTproBNP plasma concentration	NTproBNP is a Biomarker used to assess severity of congestive heart failure)	at 6 months
Primary	severity of congestive heart failure.	Ejection fraction	at baseline
Primary	severity of congestive heart failure.	Ejection fraction	at 6 months
Secondary	change in plasma potassium concentration	plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan	every month, up to 6 months
Secondary	change in serum sodium concentration	serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan	every month, up to 6 months
Secondary	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