Back to resultsPharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
Primary Purpose
Heart Failure, Systolic
Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Sacubitril / Valsartan Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic
Eligibility Criteria
Inclusion Criteria:
- 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. -
Exclusion Criteria:
- 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-
Sites / Locations
- Ringerike Hospital Vestre Viken Hospital TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Increasing doses of Sacubitril/Valsartan
Outcomes
Primary Outcome Measures
Neurohormonal plasma concentration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03553303
Brief Title
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
Official Title
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Increasing doses of Sacubitril/Valsartan
Intervention Type
Drug
Intervention Name(s)
Sacubitril / Valsartan Oral Tablet
Intervention Description
Increasing doses of Sacubitril/Valsartan
Primary Outcome Measure Information:
Title
Neurohormonal plasma concentration
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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. -
Exclusion Criteria:
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-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Hall, MD PhD
Phone
+4747500900
Email
chall@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingeborg Haugli, MD
Phone
+4791887090
Email
ingeborg.haugli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Hall, MD PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Ringerike Hospital Vestre Viken Hospital Trust
City
Hønefoss
State/Province
Buskerud
ZIP/Postal Code
3511
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hall
Phone
+4747500900
First Name & Middle Initial & Last Name & Degree
Hall
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
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