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

University of Oslo (UIO)

Status and phase: Unknown; Phase 4

Conditions: Heart Failure, Systolic

Treatments: Drug: Sacubitril / Valsartan Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03553303

3403003

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention

Experimental group

Description:

Increasing doses of Sacubitril/Valsartan

Treatment:

Drug: Sacubitril / Valsartan Oral Tablet