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| Name | Class |
|---|---|
| Cairo University | OTHER |
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Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR < 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease & presenting with decompensated heart failure has not yet been explored fully.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril / Valsartan | Experimental |
| |
| Ramipril | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril / Valsartan | Drug | Patients will receive sacubitril/valsartan at an initial dose of 24/26 mg Bid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in each group who develop worsening renal function throughout the study period. | Defined as a 50% increase in the serum creatinine level (mg/dL) from baseline and/or a drop in eGFR by more than 25 ml/min/1.73m2. | 12 weeks |
| Number of events in each group for hyperkalemia throughout the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| HF rehospitalization: this will include the total number of patients in each group who will require hospital re-admission for ADHF. | 12 weeks | |
| All-cause mortality: this will include the total number of deaths in each group regardless of the underlying cause. |
Inclusion Criteria: All the following should be met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hesham Salah Eldin Taha, MD | Cairo University | Study Director |
| Omar Younis, Msc | National Heart Institiute, Cairo - Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | Egypt | ||||
| National Heart Institute |
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| Ramipril (ACE-inhibitor) | Drug | Patients will receive ramipril at an initial dose of 2.5 mg Bid. |
|
Defined as a rise in serum potassium level to ≥ 5.5 mEq/L . |
| 12 weeks |
| Number of events in each group for symptomatic hypotension throughout the study period. | Defined as the subjective sense of dizziness or lightheadedness, blurred, or fading of vision, fainting, fatigue, difficulty concentrating and/or nausea in the presence of a BP of 90/60mmHg or lower. | 12 weeks |
| Number of events in each group for angioedema throughout the study period. | Defined as a swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal tissues. | 12 weeks |
| Difference between uACR levels (gm/mg) in each group at 12 weeks post-randomization. | 12 weeks |
| Difference between NT-proBNP levels (pg/mL) in each group at 12 weeks post-randomization | 12 weeks |
| Difference between LVEF (%) of each group at 12 weeks post-randomization | 12 weeks |
| 12 weeks |
| Cairo |
| Egypt |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D017257 | Ramipril |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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