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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sacubitril-Valsartan
Valsartan
Sponsored by
Amir Safwat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wadi El-Neel Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacubitril/valsartan

Valsartan

Arm Description

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

Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.

Outcomes

Primary Outcome Measures

change in NTproBNP plasma concentration
NTproBNP is a Biomarker used to assess severity of congestive heart failure)
change in NTproBNP plasma concentration
NTproBNP is a Biomarker used to assess severity of congestive heart failure)
severity of congestive heart failure.
Ejection fraction
severity of congestive heart failure.
Ejection fraction

Secondary Outcome Measures

change in plasma potassium concentration
plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan
change in serum sodium concentration
serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan
change in serum creatinine
serum creatinine which is a byproduct of muscle protein metabolism is used to evaluate Sacubitril-Valsartan

Full Information

First Posted
December 19, 2020
Last Updated
June 18, 2022
Sponsor
Amir Safwat
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1. Study Identification

Unique Protocol Identification Number
NCT04688294
Brief Title
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Official Title
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amir Safwat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. New York Heart Association (NYHA) Class. Frequency of hospitalization by acute exacerbation of CHF NT-ProBNP Left ventricular systolic function by Echocardiography Moreover, the side effects of the drugs used during study was assessed by Renal function (Serum creatinine) was performed every month till the end of the study. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacubitril/valsartan
Arm Type
Experimental
Arm Description
Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.
Arm Title
Valsartan
Arm Type
Active Comparator
Arm Description
Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.
Intervention Type
Drug
Intervention Name(s)
Sacubitril-Valsartan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in NTproBNP plasma concentration
Description
NTproBNP is a Biomarker used to assess severity of congestive heart failure)
Time Frame
at baseline
Title
change in NTproBNP plasma concentration
Description
NTproBNP is a Biomarker used to assess severity of congestive heart failure)
Time Frame
at 6 months
Title
severity of congestive heart failure.
Description
Ejection fraction
Time Frame
at baseline
Title
severity of congestive heart failure.
Description
Ejection fraction
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
change in plasma potassium concentration
Description
plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan
Time Frame
every month, up to 6 months
Title
change in serum sodium concentration
Description
serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan
Time Frame
every month, up to 6 months
Title
change in serum creatinine
Description
serum creatinine which is a byproduct of muscle protein metabolism is used to evaluate Sacubitril-Valsartan
Time Frame
every month, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 - 60 years Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification Left Ventricular Ejection Fraction of 40% or less. NT-proBNP level of at least ≥400 pg per milliliter ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day. Exclusion Criteria: Patients with symptomatic hypotension. Pregnant and nursing women Systolic blood pressure < 100 mmHg at screening or < 95 mmHg at randomization Patients with glomerular filtration rate <30 mL/min/1.73 m2 Patients with history of angioedema Patients with unacceptable side effects with ACE-inhibitors or ARBs.
Facility Information:
Facility Name
Wadi El-Neel Hospital
City
Cairo
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

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

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