Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction

Heart Failure, Systolic Clinical Trial

Official title:

Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05387967
• Other study ID #: ERC-05/2020
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: National Institute of Cardiovascular Diseases, Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Either gender
• between 18 to 80 years of age
• Diagnosed with Heart failure with reduced ejection fraction (HFrEF)
• New York Heart Association (NYHA) class II-IV
• Left ventricular ejection fraction (LVEF) = 40%
• Stable on any dose of beta-blockers, ACEI or ARB

Exclusion Criteria:

• Refused to participate in the study
• Patients with hyperkalemia
• Patients with hypotension
• Patients with renal dysfunction
• History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• Sacubitril/valsartan
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.

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Karachi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	Systolic blood pressure <90 mmHg	12 weeks
Primary	Incidence of renal dysfunction	estimated glomerular filtration rate (eGFR) <30 ml/min	12 weeks
Primary	Incidence of renal hyperkalemia	Potassium >5.2 mmol/L	12 weeks
Primary	Incidence of renal angioedema	Rapid edema, or swelling, of the area beneath the skin or mucosa	12 weeks
Primary	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