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

Primary Purpose

Heart Failure, Systolic

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Sacubitril/valsartan
Sponsored by
National Institute of Cardiovascular Diseases, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Cardiovascular Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of hypotension
Systolic blood pressure <90 mmHg
Incidence of renal dysfunction
estimated glomerular filtration rate (eGFR) <30 ml/min
Incidence of renal hyperkalemia
Potassium >5.2 mmol/L
Incidence of renal angioedema
Rapid edema, or swelling, of the area beneath the skin or mucosa
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

Secondary Outcome Measures

Full Information

First Posted
May 13, 2022
Last Updated
May 20, 2022
Sponsor
National Institute of Cardiovascular Diseases, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05387967
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiovascular Diseases, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label non-randomized clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sacubitril/valsartan
Other Intervention Name(s)
Angiotensin receptor blocker and neprilysin inhibitor (ARNI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
Systolic blood pressure <90 mmHg
Time Frame
12 weeks
Title
Incidence of renal dysfunction
Description
estimated glomerular filtration rate (eGFR) <30 ml/min
Time Frame
12 weeks
Title
Incidence of renal hyperkalemia
Description
Potassium >5.2 mmol/L
Time Frame
12 weeks
Title
Incidence of renal angioedema
Description
Rapid edema, or swelling, of the area beneath the skin or mucosa
Time Frame
12 weeks
Title
Frequency of tolerability
Description
Defined as the dose tolerated by the patients which did not require down titration or discontinuation of prescribed dose during follow-up
Time Frame
During 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Nauman Khan, FCPS
Organizational Affiliation
National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cardiovascular Diseases
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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