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Completed

NCT Number: NCT01870739

A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

sacubitril/valsartan (LCZ696)

Drug

200 mg tablets

Olmesartan

Drug

placebo to sacubitril/valsartan (LCZ696)

Other

placebo

placebo to olmesartan

Other

placebo

Amlodipine (Optional)

Drug

If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Primary outcomes

  1. Change From Baseline in Ascending Aorta Distensibility at 52 Week

    Time frame: Baseline, 52 weeks

    Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.

  2. Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks

    Time frame: Baseline, 52 weeks

    Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.

  3. Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks

    Time frame: Baseline, 52 weeks

    Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.

Secondary outcomes

  1. Change From Baseline in Local Aortic Strain at 52 Weeks

    Time frame: Baseline, 52 weeks

    Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.

  2. Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks

    Time frame: Baseline, 52 weeks

    Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.

  3. Change From Baseline in Central Blood Pressure at 52 Weeks

    Time frame: Baseline, 52 weeks

    Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.

  4. Change From Baseline in Augmentation Pressure at 52 Weeks

    Time frame: Baseline, 52 weeks

    Augmentation pressure is the added pressure during systole due to wave reflection.

  5. Change From Baseline in Augmentation Index at 52 Weeks

    Time frame: Baseline, 52 weeks

    Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.

  6. Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks

    Time frame: Baseline, 52 weeks

    For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.

  7. Number of Patients With Reported Adverse Events, Serious Adverse Events and Death

    Time frame: 12 weeks

    This outcome measure summarizes patients with any adverse events, serious adverse events and death.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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