Heart Failure
Conditions
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.
Interventions
DRUGSacubitril-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
DRUGValsartan
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.
Sponsors
Amir Safwat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in NTproBNP plasma concentration | at baseline | NTproBNP is a Biomarker used to assess severity of congestive heart failure) |
| severity of congestive heart failure. | at baseline | Ejection fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in plasma potassium concentration | every month, up to 6 months | plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan |
| change in serum sodium concentration | every month, up to 6 months | serum sodium (extracellular 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 |
Countries
Egypt
Outcome results
None listed