Trials / Completed
CompletedNCT02874794
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction
A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active-controlled, Forced-titration, 12-week Comparison of Combined Angiotensin-neprilysin Inhibition With Sacubitril and Valsartan Versus Enalapril on Changes in Central Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 465 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LCZ696 (sacubitril/valsartan) | 24/26mg, 49/51mg and 97/103mg oral, tablets. |
| DRUG | Enalapril | 2.5mg, 5mg, and 10mg, oral, tablets |
| DRUG | Placebo of Enalapril | matching placebo (2.5mg, 5mg and 10mg) oral, tablets |
| DRUG | Placebo of LCZ696 | matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets |
Timeline
- Start date
- 2016-08-17
- Primary completion
- 2018-12-13
- Completion
- 2019-01-26
- First posted
- 2016-08-22
- Last updated
- 2021-01-05
- Results posted
- 2020-03-19
Locations
81 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02874794. Inclusion in this directory is not an endorsement.