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Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03553303
Enrollment
40
Registered
2018-06-12
Start date
2018-10-16
Completion date
2022-05-31
Last updated
2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic

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.

Interventions

Increasing doses of Sacubitril/Valsartan

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients must give written informed consent before any study assessment is performed. 2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital. 3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%). 4. Patients on optimized medical treatment for heart failure. -

Exclusion criteria

1. Patients not able to comply in the study. 2. Patients having contraindication for treatment with Entresto; 1. Hypersensitivity to the active substances or to any of the excipients listed in section 2. Hyperkalemia: \> 5.4 mmol/L 3. Known history of angioedema related to previous ACE inhibitor or ARB therapy. 4. Hereditary or idiopathic angioedema. 5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2) 6. End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis). 7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification). 8. Pregnancy Breast-feeding-

Design outcomes

Primary

MeasureTime frame
Neurohormonal plasma concentration8 weeks

Countries

Norway

Contacts

Primary ContactChristian Hall, MD PhD
chall@medisin.uio.no+4747500900
Backup ContactIngeborg Haugli, MD
ingeborg.haugli@gmail.com+4791887090‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026