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

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ClinicalTrials.gov Identifier: NCT03553303
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Hall, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Drug: Sacubitril / Valsartan Oral Tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan

Arm Intervention/treatment
Experimental: Intervention
Increasing doses of Sacubitril/Valsartan
Drug: Sacubitril / Valsartan Oral Tablet
Increasing doses of Sacubitril/Valsartan




Primary Outcome Measures :
  1. Neurohormonal plasma concentration [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553303


Contacts
Contact: Christian Hall, MD PhD +4747500900 chall@medisin.uio.no
Contact: Ingeborg Haugli, MD +4791887090‬ ingeborg.haugli@gmail.com

Locations
Norway
Ringerike Hospital Vestre Viken Hospital Trust Recruiting
Hønefoss, Buskerud, Norway, 3511
Contact: Christian Hall    +4747500900      
Contact: Hall         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Christian Hall, MD PhD University of Oslo

Responsible Party: Christian Hall, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03553303     History of Changes
Other Study ID Numbers: 3403003
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action