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Coronary Artery DiseasePhase 2NCT01979614

Study of the Vascular Effects of Serelaxin

A Phase 2 study testing Serelaxin in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Serelaxin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
3 sitesUnited Kingdom
Study dates
3 Feb 2014to 17 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Novartis Investigative Site

    Clydebank, West Dumbartonshire, G81 4HX

  • Novartis Investigative Site

    Edinburgh, EHN 2XU

  • Novartis Investigative Site

    Leicester, LE3 9QP

Other trials in United Kingdom

About this study

Official title: A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-controlled Study to Evaluate the Effects of Intravenous Serelaxin Infusion on Micro- and Macrovascular Function in Patients With Coronary Artery Disease

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

Read the detailed description

double blind, randomized, parallel group, placebo controlled study

Being tested
Serelaxin, Placebo
Keywords
coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerelaxinDrug

    Also called RLX030, relaxin

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

  • PlaceboOther

    5% v/v glucose solution

Study groups in NCT01979614
Study groupRoleWhat they receive
SerelaxinExperimentalSerelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
Receives: Drug: Serelaxin
PlaceboPlacebo comparatorPlacebo was administered by intravenous infusion for 48 hours
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline to Day 3

Secondary outcomes (8)

  1. 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)

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

  2. 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

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

  3. 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

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

  4. Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance

    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

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

  5. Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis

    Pulse wave velocity was assessed by the SphygmoCor device

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

  6. Serum Concentration of Serelaxin

    Summary statistics of serelaxin serum PK concentrations

    Blood samples were taken to measure serelaxin concentration

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

  7. 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

    Measured: From pre-dose on Day 1 until Day 30 after the start of drug infusion

  8. Systemic Clearance of Serelaxin

    Systemic clearance was estimated using the rate of serelaxin infusion and the steady state concentration

    Measured: From pre-dose on Day 1 until 48h after the start of drug infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study start3 Feb 2014
  3. Primary completion17 Aug 2016
  4. Study completion17 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double blind, randomized, parallel group, placebo controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01979614
Sponsor's protocol ID
CRLX030A2203
Other IDs
2012-001945-42
Status last verified
Apr 2019
First submitted
4 Nov 2013
Last updated
1 Jul 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serelaxin in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points (time frame: baseline to Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.

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