Study of the Vascular Effects of Serelaxin

NCT ID: NCT01979614

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-03
• Study Completion Date: 2016-08-17

Brief Summary

This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.

Detailed Description

double blind, randomized, parallel group, placebo controlled study

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Serelaxin

Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution

Placebo

Placebo was administered by intravenous infusion for 48 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

5% v/v glucose solution

Interventions

Serelaxin

Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution

Intervention Type: DRUG

Placebo

5% v/v glucose solution

Intervention Type: OTHER

Other Intervention Names

RLX030, relaxin

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Clydebank, West Dumbartonshire, United Kingdom

Novartis Investigative Site

Edinburgh, , United Kingdom

Novartis Investigative Site

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2012-001945-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRLX030A2203

Identifier Type: -

Identifier Source: org_study_id