Phase 2
N=58
Study of the Vascular Effects of Serelaxin
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01979614 ↗Enrolled (actual)
58
Serious AEs
20.7%
Results posted
Jul 2019
Primary outcome: Primary: Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points — -0.244; -0.133; -0.264; -0.075 ratio — p=0.438
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Serelaxin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points |
-0.244; -0.133; -0.264; -0.075 | 0.438 |
| SECONDARY Change From Baseline in Aortic Distensibility Measured by MRI |
0.0017; 0.0014; 0.0015; 0.0015; 0.0023; 0.0019 | — |
| SECONDARY Change From Baseline in Aortic Velocity |
127.981; 106.557; 127.981; 106.557 | — |
| SECONDARY Change From Baseline in Augmentation Index Measured From Sphygmocor Device |
-4.12; -2.48; -2.99; -0.58; -0.82; 0.22 | — |
| SECONDARY Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance |
-4.088; -1.970; -3.277; -0.394; -0.774; 0.070 | — |
| SECONDARY Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis |
7.453; 8.166; 7.051; 7.677; 7.195; 8.264 | — |
| SECONDARY Serum Concentration of Serelaxin |
0.637; 27600; 26300; 7940; 3960; 0.00 | — |
| SECONDARY Serum Concentration of Antibodies to Serelaxin |
100; 100; 0; 0; 100; 100 | — |
| SECONDARY Systemic Clearance of Serelaxin |
107 | — |
Summary
This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.
Eligibility Criteria
Inclusion Criteria
- Male and female patients ≥18 years of age, with body weight 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis).
- Clinical diagnosis of acute coronary syndrome (ACS) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
- Troponin elevation and dynamics indicative of ACS at any time between screening and randomization.
- Previous myocardial infarction within 3 months of screening
- History of Coronary Artery Bypass Graft (CABG) surgery
- Heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate 120 beats per minute)
- Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease)
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Data sourced from ClinicalTrials.gov (NCT01979614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.