- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05387967
Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Sindh
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Karachi, Sindh, Pakistan, 75510
- National Institute of CardioVascular Diseases
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment group
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.
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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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of hypotension
Tidsramme: 12 weeks
|
Systolic blood pressure <90 mmHg
|
12 weeks
|
Incidence of renal dysfunction
Tidsramme: 12 weeks
|
estimated glomerular filtration rate (eGFR) <30 ml/min
|
12 weeks
|
Incidence of renal hyperkalemia
Tidsramme: 12 weeks
|
Potassium >5.2 mmol/L
|
12 weeks
|
Incidence of renal angioedema
Tidsramme: 12 weeks
|
Rapid edema, or swelling, of the area beneath the skin or mucosa
|
12 weeks
|
Frequency of tolerability
Tidsramme: During 12 weeks
|
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Muhammad Nauman Khan, FCPS, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ERC-05/2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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