Study of the Vascular Effects of Serelaxin
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Serelaxin; Placebo
Intervention description: Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution; 5% v/v glucose solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, randomized, parallel group, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronary artery disease

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 <160 kg.

          -  Patients with proven obstructive coronary artery disease, determined either by
             functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g.
             stress-echo, PET or SPECT myocardial perfusion), or invasive coronary angiography or
             by CT coronary angiography at any point in time in patients with or without mild left
             ventricular systolic dysfunction (LVSD)

        Exclusion Criteria:

          -  Previous treatment with serelaxin (also known as: RLX030, relaxin)

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective methods of contraception
             during dosing of study treatment.

          -  Current or planned dialysis.

          -  Impaired renal function during screening defined as an estimated glomerular filtration
             rate (eGFR) at screening and prior to treatment of <30 mL/min/1.73 m2, calculated
             using the simplified Modification of Diet in Renal Disease (sMDRD) equation due to
             potential issue with administration of GdDTPA used as the MRI contrast agent.

          -  Sick-Sinus-Syndrome

          -  Current or history of pulmonary edema, including suspected sepsis.

          -  restrictive, or constrictive cardiomyopathy (does not include restrictive mitral
             filling patterns seen on Doppler echocardiographic assessments of diastolic function)

          -  Known significant valvular disease (including any of the following: severe aortic
             stenosis [AVA < 1.0 or peak gradient > 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 < 45 beats per minute
             or any second or third degree AV block or atrial fibrillation/flutter with ventricular
             response of > 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).