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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03553303
Other study ID # 3403003
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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-

Study Design


Related Conditions & MeSH terms


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
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