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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: LCZ 696; Valsartan

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-