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

The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.

Study Overview

• Status: Unknown
• Conditions: Heart Failure, Systolic
• Intervention / Treatment: Drug: Sacubitril / Valsartan Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christian Hall, MD PhD; Phone Number: +4747500900; Email: chall@medisin.uio.no
• Study Contact Backup: Name: Ingeborg Haugli, MD; Phone Number: +4791887090‬; Email: ingeborg.haugli@gmail.com

Study Locations

• Norway
  • Buskerud
    • Hønefoss, Buskerud, Norway, 3511
      • Recruiting
      • Ringerike Hospital Vestre Viken Hospital Trust
      • Contact: Christian Hall; Phone Number: +4747500900
      • Contact: Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Increasing doses of Sacubitril/Valsartan	Drug: Sacubitril / Valsartan Oral Tablet; Increasing doses of Sacubitril/Valsartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurohormonal plasma concentration	8 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Christian Hall, MD PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2018
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: 3403003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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