This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.
double blind, randomized, parallel group, placebo controlled study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Novartis Investigative Site
Clydebank, West Dumbartonshire, United Kingdom
Novartis Investigative Site
Edinburgh, United Kingdom
Novartis Investigative Site
Leicester, United Kingdom
Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
Time frame: baseline to Day 3
Change From Baseline in Aortic Distensibility Measured by MRI
Measurements of arterial stiffness from cardiac MRI - Mean (SD) \[n\] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device. (mmHg-1)
Time frame: At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
Change From Baseline in Aortic Velocity
Summary table for measurements of arterial velocity from cardiac MRI - Mean (SD) \[n\] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device
Time frame: At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
Summary of values and change from baseline in augmentation index by time and treatment The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance
Time frame: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
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The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave
Time frame: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
Pulse wave velocity was assessed by the SphygmoCor device
Time frame: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion
Serum Concentration of Serelaxin
Summary statistics of serelaxin serum PK concentrations Blood samples were taken to measure serelaxin concentration
Time frame: Day1, Day 2, Day 3 and Day 30 after the start of infusion
Serum Concentration of Antibodies to Serelaxin
Frequency and percentage of anti-Serelaxin antibodies Blood samples were taken to measure antibodies to serelaxin concentration at Pre-dose on Day 1, and at Day 30 after the start of the 48h drug infusion
Time frame: From pre-dose on Day 1 until Day 30 after the start of drug infusion
Systemic Clearance of Serelaxin
Systemic clearance was estimated using the rate of serelaxin infusion and the steady state concentration
Time frame: From pre-dose on Day 1 until 48h after the start of drug infusion