Evidence map›Paper›PMID 36915075›Full record

Trial reportBMC cardiovascular disorders2023

Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction.

Muhammad Nauman Khan, Najia Aslam Soomro, Khalid Naseeb, Usman Hanif Bhatti, Rubina Rauf, Iram Jehan Balouch, Ali Moazzam, Sonia Bashir, Tariq Ashraf, Musa Karim

Registry-linked trialOpen access · goldFull text readClinical Trial
In one paragraph

Trial report in BMC cardiovascular disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05387967 (Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05387967 phase4completednot on this map

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

TypeinterventionalSponsorNational Institute of Cardiovascular Diseases, PakistanRan2021 to 2021Enrolled121ConditionsHeart Failure, SystolicArmsSacubitril/valsartan
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Muhammad Nauman KhanNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan. nkhan116@yahoo.com.ORCID 0000-0002-2985-6633
Najia Aslam SoomroLiaquat National Hospital, Karachi, Pakistan.
Khalid NaseebNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
Usman Hanif BhattiNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
Rubina RaufNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
Iram Jehan BalouchNational Institute of Cardiovascular Diseases (NICVD), Hyderabad, Pakistan.
Ali MoazzamNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
Sonia BashirNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
Tariq AshrafKarachi Institute of Heart Diseases (KIHD), Karachi, Pakistan.
Musa KarimNational Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan.
National Institute of Cardiovascular Diseases · PKKarachi Institute of Heart Diseases · PKLiaquat National Hospital · PK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAngiotensin receptor blocker and a neprilysin inhibitor (ARNI) has emerged as an innovative therapy for patients of heart failure with reduced ejection fraction (HFrEF). The purpose of this study was to assess the safety and tolerability of Sacubitril/Valsartan in patient with HFrEF in Pakistani population.

methodsThis proof-of-concept, open label non-randomized clinical trial was conducted at a tertiary care cardiac center of Karachi, Pakistan. Patients with HFrEF were prescribed with 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.

resultsAmong the 120 HFrEF patients, majority were male (79.2%) with means age of 52.73 ± 12.23 years. At the end of 12 weeks, four (3.3%) patients died and eight (6.7%) dropped out of the study. In the remaining 108 patients, 80.6% (87) of the patients were tolerant to the prescribed dose. Functional class improved gradually with 75.0% (81) in class I and 24.1% (26) in class II, and only one (0.9%) patient in class III at the end of 12 weeks. Hyperkalemia remains the main safety concern with incidence rate of 21.3% (23) followed by hypotension in 19.4% (21), and renal dysfunction in 3.7% (4) of the patients.

conclusionsSacubitril/Valsartan therapy in HFrEF patients is safe and moderately tolerated among the Pakistani population. It can be used as first line of treatment for these patients.

trial registrationNCT05387967. Registered 24 May 2022-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05387967.

Indexed as

Heart FailureValsartanVentricular Dysfunction, LeftAdultAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsFemaleHumansHyperkalemiaHypotensionKidney DiseasesMaleMiddle AgedStroke VolumeTetrazolesAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundssacubitrilTetrazolesValsartanHeart failureReduced ejection fractionSacubitrilSafety and tolerability

Identifiers

PMID36915075
PMCPMC10012729
OpenAlexW4324045906

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read131
identifiers read1
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.