Clinical trial NCT01870739: A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Official title: A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: LCZ696,
Hypertension,
Aortic stiffness,
Central blood pressure,
Cardiovascular MRI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* Subjects with essential hypertension, untreated or currently taking antihypertensive therapy

Key exclusion Criteria:

* women of child bearing potential (WOCBP) if not on highly effective contraception
* Malignant or severe hypertension (grade 3 of WHO classification)
* History or evidence of a secondary form of hypertension
* Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
* Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).

Primary outcomes:
measure: Change From Baseline in Ascending Aorta Distensibility at 52 Week
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change From Baseline in Local Aortic Strain at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Central Blood Pressure at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Augmentation Pressure at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Augmentation Index at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
state: Scotland
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.