A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Summary
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-06
- Completion
- 2015-06
Outcome
Missed primary endpoint
registry Sacubitril/Valsartan (LCZ696) vs Olmesartan; p = 0.7324; Mean Difference (Net) -0.0616 (95% CI -0.4178 to 0.2947) NCT01870739 ↗
registry Sacubitril/Valsartan (LCZ696) vs Olmesartan; p = 0.8614; Mean Difference (Net) -0.0371 (95% CI -0.4582 to 0.3839) NCT01870739 ↗
registry Sacubitril/Valsartan (LCZ696) vs Olmesartan; p = 0.7946; Mean Difference (Net) -0.0812 (95% CI -0.6987 to 0.5362) NCT01870739 ↗
Publications
- Hrabak-Paar M, Kircher A, Al Sayari S, Kopp S, Santini F, Schmieder RE, Kachenoura N, Yates D, Langenickel T, Bremerich J, Heye T. Variability of MRI Aortic Stiffness Measurements in a Multicenter Clinical Trial Setting: Intraobserver, Interobserver, and Intracenter Variability of Pulse Wave Velocity and Aortic Strain Measurement. Radiol Cardiothorac Imaging. 2020 Apr 30;2(2):e190090. doi: 10.1148/ryct.2020190090. eCollection 2020 Apr.
- Santini F, Pansini M, Hrabak-Paar M, Yates D, Langenickel TH, Bremerich J, Bieri O, Schubert T. On the optimal temporal resolution for phase contrast cardiovascular magnetic resonance imaging: establishment of baseline values. J Cardiovasc Magn Reson. 2020 Oct 5;22(1):72. doi: 10.1186/s12968-020-00669-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Olmesartan | Other / unclassified | 40 mg | — |
| Subject | sacubitril/valsartan | Unknown | 400 mg | — |
| Background | Amlodipine | Other / unclassified | 2.5 mg | — |
| Background | Amlodipine | Other / unclassified | 5 mg | — |
| Background | Amlodipine | Other / unclassified | 10 mg | — |