Clinical Trials Logo

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05387967
Study type Interventional
Source National Institute of Cardiovascular Diseases, Karachi
Contact
Status Completed
Phase Phase 4
Start date January 1, 2021
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT03227393 - The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG N/A
Recruiting NCT04528004 - Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure Early Phase 1
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Completed NCT05475028 - Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
Not yet recruiting NCT06240403 - Digoxin and Senolysis in Heart Failure and Diabetes Mellitus Phase 2
Not yet recruiting NCT05988749 - Digital Remote Home Monitoring for Heart Failure N/A
Recruiting NCT04950218 - The Psoriasis Echo Study
Suspended NCT04701112 - Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure N/A
Completed NCT03305692 - ECG Belt vs. Echocardiographic Optimization of CRT N/A
Recruiting NCT05933083 - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation N/A
Enrolling by invitation NCT03903107 - The Fluoroless-CSP Trial Using Electroanatomic Mapping N/A
Withdrawn NCT04872959 - TRANSFORM Heart Failure With Reduced Ejection Fraction N/A
Completed NCT02920918 - Treatment of Diabetes in Patients With Systolic Heart Failure Phase 4
Completed NCT02334891 - Kyoto Congestive Heart Failure Study
Recruiting NCT03553303 - Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin Phase 4
Recruiting NCT04083690 - Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients N/A
Recruiting NCT03830957 - Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker N/A
Recruiting NCT06121323 - Physiological Effects of Lactate in Individuals With Chronic Heart Failure N/A
Completed NCT03351283 - Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure N/A