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Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure (RELAX-Cardio)

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ClinicalTrials.gov Identifier: NCT02625922
Recruitment Status : Terminated (In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.)
First Posted : December 9, 2015
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Serelaxin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care
Study Start Date : February 5, 2016
Actual Primary Completion Date : January 11, 2017
Actual Study Completion Date : January 11, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Serelaxin followed by Placebo
On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
 Drug: Serelaxin
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
Other Name: RLX030

Drug: Placebo
Matching placebo i.v infusion
Experimental: Placebo followed by Serelaxin
On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
 Drug: Serelaxin
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
Other Name: RLX030

Drug: Placebo
Matching placebo i.v infusion


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo [ Time Frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1) ]
    This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.


Secondary Outcome Measures :
  1. Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours [ Time Frame: 4 and 5 hours after exercise testing session ]
    This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.

  2. Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo [ Time Frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) ]
    This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.

  3. Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo [ Time Frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) ]
    This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female ≥ 18 years of age, with body weight ≤ 160 Kg

  • Diagnosis of stable CHF:

    • New York Heart Association (NYHA) functional Class II/III.
    • Receiving guideline-recommended treatment for CHF.
  • Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to screening.
  • NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined locally).
  • Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
  • Systolic BP ≥ 125 mmHg at randomization
  • Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD formula).

Key Exclusion Criteria:

  • Dyspnea primarily due to non-cardiac causes.
  • Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
  • Any contraindication for exercise testing and spirometry.
  • Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05.
  • Change in guideline-recommended CHF treatment within 1 month prior to screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625922


Locations
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Germany
Novartis Investigative Site
Greifswald, Mecklenburg Vorpommern, Germany, 17475
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Muenchen, Germany, 80636
Novartis Investigative Site
Muenchen, Germany, 81675
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
United Kingdom
Novartis Investigative Site
Hull, United Kingdom, HU16 5JQ
Novartis Investigative Site
London, United Kingdom, SW 6NP
Novartis Investigative Site
Tyne And Wear, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02625922    
Other Study ID Numbers: CRLX030A2211
2015-002673-38 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Serelaxin,
Chronic heart failure,
Spiroergometry,
 Troponin,
New York Heart Association (NYHA) functional Class II/III,
Left ventricular ejection fraction,
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases