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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)

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Serelaxin
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Serelaxin,, Chronic heart failure,, Spiroergometry,, Troponin,, New York Heart Association (NYHA) functional Class II/III,, Left ventricular ejection fraction,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Serelaxin followed by Placebo

Placebo followed by Serelaxin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.

Secondary Outcome Measures

Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.

Full Information

First Posted
December 3, 2015
Last Updated
January 11, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02625922
Brief Title
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Acronym
RELAX-Cardio
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.
Study Start Date
February 5, 2016 (undefined)
Primary Completion Date
January 11, 2017 (Actual)
Study Completion Date
January 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Serelaxin,, Chronic heart failure,, Spiroergometry,, Troponin,, New York Heart Association (NYHA) functional Class II/III,, Left ventricular ejection fraction,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serelaxin followed by Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo followed by Serelaxin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Serelaxin
Other Intervention Name(s)
RLX030
Intervention Description
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo i.v infusion
Primary Outcome Measure Information:
Title
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo
Description
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
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)
Secondary Outcome Measure Information:
Title
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours
Description
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Time Frame
4 and 5 hours after exercise testing session
Title
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
Description
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
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)
Title
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
Description
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Greifswald
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
17475
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80636
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW 6NP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Tyne And Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom

12. IPD Sharing Statement

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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

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