Study of the Vascular Effects of Serelaxin

NCT01979614 | Completed Phase 2 Results

• 2 other identifiers: CRLX030A22032012-001945-42
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

  baseline to Day 3

Secondary Outcomes (8)

• Change From Baseline in Aortic Distensibility Measured by MRI

  At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion

• Change From Baseline in Aortic Velocity

  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

  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

  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

  Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion

Study Arms (2)

Serelaxin

EXPERIMENTAL

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

Drug: Serelaxin

Placebo

PLACEBO COMPARATOR

Placebo was administered by intravenous infusion for 48 hours

Other: Placebo

Interventions

Serelaxin DRUG

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

Also known as: RLX030, relaxin

Serelaxin

Placebo OTHER

5% v/v glucose solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Clydebank, West Dumbartonshire, G81 4HX, United Kingdom

Location

Novartis Investigative Site

Edinburgh, EHN 2XU, United Kingdom

Location

Novartis Investigative Site

Leicester, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

serelaxin protein, human; Relaxin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double blind, randomized, parallel group, placebo controlled study

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: February 3, 2014
• Primary Completion: August 17, 2016
• Study Completion: August 17, 2016
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-04

Locations

GB (3)