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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.
Moreover, the side effects of the drugs used during study was assessed by
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/valsartan | Experimental | Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy. |
|
| Valsartan | Active Comparator | Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril-Valsartan | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in NTproBNP plasma concentration | NTproBNP is a Biomarker used to assess severity of congestive heart failure) | at baseline |
| change in NTproBNP plasma concentration | NTproBNP is a Biomarker used to assess severity of congestive heart failure) | at 6 months |
| severity of congestive heart failure. | Ejection fraction | at baseline |
| severity of congestive heart failure. | Ejection fraction | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in plasma potassium concentration | plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan | every month, up to 6 months |
| change in serum sodium concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wadi El-Neel Hospital | Cairo | 11865 | Egypt |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Valsartan | Drug | 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. |
|
serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan
| every month, up to 6 months |
| 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 |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |