The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
NCT ID: NCT04688294
Last Updated: 2022-06-24
Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2020-01-01
2021-07-01
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sacubitril/valsartan
Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.
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
Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
60 Years
ALL
No
Sponsors
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Amir Safwat
OTHER
Responsible Party
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Amir Safwat
Teaching assistant
Locations
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Wadi El-Neel Hospital
Cairo, , Egypt
Countries
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Other Identifiers
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3/2019
Identifier Type: -
Identifier Source: org_study_id
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