Differential Vascular and Endocrine Effects of Valsartan/Sacubitril in Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Trial end date: 2020-09-05
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate whether valsartan/sacubitril leads to a superior improvement in endothelial function and endocrine status compared to valsartan alone.

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

Details

• Lead Sponsor: University of Zurich
• Collaborator: Novartis Pharmaceuticals
• Treatments: LCZ 696; Valsartan

Criteria

Inclusion Criteria:

1. Patients ≥ 18 years of age, male or female, with a diagnosis of symptomatic heart failure (NYHA class II-IV) per ESC heart failure guidelines

2. LVEF ≤ 40%

3. Established guideline-recommended therapy with an ACEI, ARB and a beta-blocker, as clinically indicated and tolerated, at stable doses for at least 3 weeks prior to inclusion.

Exclusion Criteria:

1. History of hypersensitivity or allergy to any of the study drugs

2. History of angioedema.

3. Sitting systolic blood pressure <90 mmHg at Visit 1 (screening) or Visit 2 (randomization)

4. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).

5. Estimated GFR < 20 mL/min/1.73m2

6. Serum potassium > 5.5 mmol/L at Visit 1 (screening) or Visit 2 (randomization).

7. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.

8. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1.

9. Implantation of a cardiac resynchronization therapy device (CRTD) within 2 months prior Visit 1 or intent to implant a CRTD within next 3 months.

10. History of heart transplant, on a transplant list or with ventricular assistance device (VAD).

11. Presence of significant endocrine diseases.

12. Presence of active acute infectious diseases.

13. Known narrow-angle glaucoma

14. Known epilepsy

15. Cimino-shunt operation on both arms

16. Pregnancy, intention thereof during study; lack of sufficient contraception; breastfeeding