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This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema
A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were obtained. Inclusion criteria for the study were either gender between 18 to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia, hypotension, renal dysfunction, and a history of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were excluded from the study.
All the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID) for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication adherence level using the Dose-Nonadherence scale. All the patients were kept under a close follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and tolerability outcomes were assessed as per the operational definition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril/valsartan | Drug | All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | Systolic blood pressure <90 mmHg | 12 weeks |
| Incidence of renal dysfunction | estimated glomerular filtration rate (eGFR) <30 ml/min | 12 weeks |
| Incidence of renal hyperkalemia | Potassium >5.2 mmol/L | 12 weeks |
| Incidence of renal angioedema | Rapid edema, or swelling, of the area beneath the skin or mucosa | 12 weeks |
| Frequency of tolerability | Defined as the dose tolerated by the patients which did not require down titration or discontinuation of prescribed dose during follow-up | During 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Nauman Khan, FCPS | National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiovascular Diseases | Karachi | Sindh | 75510 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36915075 | Derived | Khan MN, Soomro NA, Naseeb K, Bhatti UH, Rauf R, Balouch IJ, Moazzam A, Bashir S, Ashraf T, Karim M. Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction. BMC Cardiovasc Disord. 2023 Mar 13;23(1):133. doi: 10.1186/s12872-023-03070-9. |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D057911 | Angiotensin Receptor Antagonists |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Open label non-randomized clinical trial
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