Clinical trial NCT05387967: Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
Official title: Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Systolic
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label non-randomized clinical trial
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypotension
timeFrame: 12 weeks
measure: Incidence of renal dysfunction
timeFrame: 12 weeks
measure: Incidence of renal hyperkalemia
timeFrame: 12 weeks
measure: Incidence of renal angioedema
timeFrame: 12 weeks
measure: Frequency of tolerability
timeFrame: During 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
name: Muhammad Nauman Khan, FCPS
role: PRINCIPAL_INVESTIGATOR
References: