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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)

This study has been terminated.
(Study was terminated based on results from pivotal adult AHF study CRLX030A2301)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02625922
First received: December 3, 2015
Last updated: June 22, 2017
Last verified: June 2017
  Purpose
This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study to evaluate 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 Intervention Phase
Chronic Heart Failure Drug: Serelaxin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • High sensitivity cardiac troponin I (hs-cTnI) concentration after exercise compared to placebo [ Time Frame: Baseline, up to 5 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 will be obtained to determine plasma concentrations following a cardiac stress test.


Secondary Outcome Measures:
  • High sensitivity cardiac troponin I (hs-cTnI) concentrations after exercise compared to placebo [ Time Frame: 4 and 5 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 will be obtained to determine plasma concentrations following a cardiac stress test.

  • N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations compared to placebo [ Time Frame: Baseline, up to 5 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 will be obtained to determine plasma concentrations following a cardiac stress test.

  • Heart-type fatty acid-binding protein (H-FABP) concentrations compared to placebo [ Time Frame: Baseline, up to 5 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 will be obtained to determine plasma concentrations following a cardiac stress test.

  • Number of patients reported with total adverse events and serious adverse events [ Time Frame: From signature of consent until 30 days after last study visit (maximum 75 days) ]
    Number of patients reported with adverse events and serious adverse events.


Enrollment: 24
Actual Study Start Date: February 5, 2016
Study Completion Date: January 11, 2017
Primary Completion Date: January 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 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
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, 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
Drug: Placebo
Matching placebo i.v infusion

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 mm Hg 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02625922

Locations
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 & Wear, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02625922     History of Changes
Other Study ID Numbers: CRLX030A2211
2015-002673-38 ( EudraCT Number )
Study First Received: December 3, 2015
Last Updated: June 22, 2017

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017