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

NCT05387967 | Completed Phase 4

• 1 other identifier: ERC-05/2020
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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.

Drug: Sacubitril/valsartan

Interventions

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.

Also known as: Angiotensin receptor blocker and neprilysin inhibitor (ARNI)

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36915075 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

sacubitril and valsartan sodium hydrate drug combination; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Muhammad Nauman Khan, FCPS

  National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Model Details: Open label non-randomized clinical trial

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 24, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)