|
Main
|
|
Note: This record shows only 22 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:
|
12 December 2020 |
|
Main ID: |
NCT03168568 |
|
Date of registration:
|
22/05/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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:
|
79 |
|
Recruitment status: |
Completed |
|
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
| | | | | | | |
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|