Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
1 other identifier
interventional
40
1 country
1
Brief Summary
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedAugust 29, 2019
August 1, 2019
3.5 years
May 23, 2018
August 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Neurohormonal plasma concentration
8 weeks
Study Arms (1)
Intervention
EXPERIMENTALIncreasing doses of Sacubitril/Valsartan
Interventions
Eligibility Criteria
You may qualify if:
- Patients must give written informed consent before any study assessment is performed.
- Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
- Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
- Patients on optimized medical treatment for heart failure. -
You may not qualify if:
- Patients not able to comply in the study.
- Patients having contraindication for treatment with Entresto;
- Hypersensitivity to the active substances or to any of the excipients listed in section
- Hyperkalemia: \> 5.4 mmol/L
- Known history of angioedema related to previous ACE inhibitor or ARB therapy.
- Hereditary or idiopathic angioedema.
- Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2)
- End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis).
- Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
- Pregnancy Breast-feeding-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ringerike Hospital Vestre Viken Hospital Trust
Hønefoss, Buskerud, 3511, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Hall, MD PhD
University of Oslo
Central Study Contacts
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
- Professor
Study Record Dates
First Submitted
May 23, 2018
First Posted
June 12, 2018
Study Start
October 16, 2018
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
August 29, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share