Study of the Vascular Effects of Serelaxin

Browse trials for

• Coronary Artery Disease 5,598
• Myocardial Ischemia 3,233
• Coronary Disease 2,839

Keywords

• coronary artery disease

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 58 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Experimental
  Serelaxin

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

  Drug: Serelaxin

• Placebo comparator
  Placebo

  Placebo was administered by intravenous infusion for 48 hours

  Other: Placebo

Interventions

• DrugSerelaxin

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

  Also known as: RLX030, relaxin

• OtherPlacebo

  5% v/v glucose solution

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

   Time frame: baseline to Day 3

Secondary outcomes

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)

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

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

Baseline characteristics

Individual participant data

Plan to share: 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