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The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
Measurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- Follow up will be performed for assessing:
Outcomes: all patients will be followed up for 3 months for:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril-valsartan group | Active Comparator | group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment. |
|
| Control group | Placebo Comparator | Control group (n=30) on standard treatment of heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril-valsartan | Drug | patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE incidence | Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. | 3 months |
| Ejection fraction (EF%) | Ejection fraction (EF%) improvement. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP level (pg/ml) | Change in NT-proBNP level | 3 months |
| Galectin-3 level (pg/ml) | Change in Galectin-3 level | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouran A. Abu Shaara, Bachlore | Damanhour University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhur Medical National Institute | Damanhūr | Elbehairah | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39210725 | Background | Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566. | |
| 33410280 |
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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 |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
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| standard treatment of heart failure | Drug | Control group (n=30) on standard treatment of heart failure. |
|
|
| GDF-15 level (pg/ml) | Change in GDF-15 level | 3 months |
| Background |
| Lee YH, Lin PL, Chiou WR, Huang JL, Lin WY, Liao CT, Chung FP, Liang HW, Hsu CY, Chang HY. Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1204-1215. doi: 10.1002/ehf2.13182. Epub 2021 Jan 6. |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |