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

Heart Failure, Systolic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553303
• Other study ID #: 3403003
• Status: Recruiting
• Phase: Phase 4
• Start date: October 16, 2018
• Est. completion date: May 2022

Study information

• Verified date: August 2019
• Source: Oslo University Hospital
• Contact: Christian Hall, MD PhD
• Phone: +4747500900
• Email: chall[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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-

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet
Increasing doses of Sacubitril/Valsartan

Locations

Country	Name	City	State
Norway	Ringerike Hospital Vestre Viken Hospital Trust	Hønefoss	Buskerud

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurohormonal plasma concentration		8 weeks