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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 December 2018
Main ID:  NCT03168568
Date of registration: 22/05/2017
Prospective Registration: Yes
Primary sponsor: University of Zurich
Public title: Differential Vascular and Endocrine Effects of Valsartan/Sacubitril in Heart Failure With Reduced Ejection Fraction VASCEND
Scientific title: Differential Vascular and Endocrine Effects of Valsartan/Sacubitril in Heart Failure With Reduced Ejection Fraction: A Double-blind Randomized Controlled Phase IV Trial (VASCEND)
Date of first enrolment: May 4, 2017
Target sample size: 80
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03168568
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 4
Countries of recruitment
Switzerland
Contacts
Name:     Frank Ruschitzka, MD
Address: 
Telephone: +41442553353
Email: frank.ruschitzka@usz.ch
Affiliation: 
Name:     Frank Ruschitzka, Prof,MD
Address: 
Telephone: +41442553353
Email: frank.ruschitzka@usz.ch
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Heart Failure
Intervention(s)
Drug: Valsartan or placebo
Drug: Valsartan/Sacubitril or placebo
Primary Outcome(s)
Difference in flow-mediated vasodilatation (FMD) [Time Frame: Baseline, 3 months]
Secondary Outcome(s)
Difference in flicker-induced vasodilatation of retinal arterioles and venules [Time Frame: Baseline, 3 months]
Secondary ID(s)
VASCEND
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Novartis Pharmaceuticals
Results
Results available:
Date Posted:
URL:
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