Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2015-002673-38-GB |
Date of registration:
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14/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
Date of first enrolment:
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24/11/2015 |
Target sample size:
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125 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002673-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Switzerland
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United Kingdom
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Contacts
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Name:
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Medical Information Services
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley, Surrey
United Kingdom |
Telephone:
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00441276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Name:
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Medical Information Services
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley, Surrey
United Kingdom |
Telephone:
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00441276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Provide written informed consent before any assessment is
performed.
2. Male or female = 18 years of age, with body weight = 160 Kg.
3. Diagnosis of stable CHF:
- New York Heart Association (NYHA) functional Class II and III.
- Receiving guideline-recommended treatment for CHF.
4. Left ventricular ejection fraction < 50%.
5. NT-proBNP > 250 ng/L in sinus rhythm or > 750 ng/L if not in sinus
rhythm (determined locally).
6. Ability to exercise for at least 10 to 12 minutes based on
investigator's judgment.
7. Systolic BP = 125 mmHg at screening.
8. Renal function defined as an eGFR of = 25 mL/min/1.73 m2 at Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria: 1. Dyspnea primarily due to non-cardiac causes.
2. Worsening symptoms, e.g., fatigue, dyspnea, breathlessness within the 3 months prior to screening.
3. Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
4. Any contraindication for exercise testing and spirometry.
5. Stopping of the spirometry 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.
6. Change in guideline-recommended CHF treatment within 1 month prior to screening.
7. Clinical evidence of acute coronary syndrome within 90 days prior to enrollment.
8. Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest.
9.Severe renal impairment defined as eGFR < 25 mL/min/1.73m2 before randomization.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Heart Failure
MedDRA version: 19.1
Level: LLT
Classification code 10008908
Term: Chronic heart failure
System Organ Class: 100000004849
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Product Name: serelaxin Product Code: RLX030 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: SERELAXIN Current Sponsor code: RLX030 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): determine changes in plasma concentrations of hs cTnI following a cardiac stress test
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Main Objective: To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of hs-cTnI concentrations compared to placebo (both in addition to SoC) after an exercise testing session.
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Timepoint(s) of evaluation of this end point: at 0, 132, 180, 240, 300, 360, 420 minutes
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Secondary Objective: - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of hs-cTnI concentrations compared to placebo at 4 and 5 hours after the start of an exercise testing session. - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of N terminal pro-brain natriuretic peptide (NT-proBNP) concentrations after an exercise testing session. - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of heart-type fatty acid-binding protein (H-FABP). - To evaluate the safety and tolerability of i.v. serelaxin in CHF patients.
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Secondary Outcome(s)
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Secondary end point(s): - Determine changes in plasma concentrations of hs cTnI, NT-proBNP and H-FABP following a cardiac stress test. (efficacy)
- ECG, Physical examination, vital signs, Laboratory evaluation, Clinical chemistry, Hematology (safety)
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Timepoint(s) of evaluation of this end point: - efficacy: at 0, 132, 180, 240, 300, 360, 420 minutes
- safety: at screening and start of the infusion for both treatment period as well as at Day 29 (follow up period 15 days after treatment period 2)
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Secondary ID(s)
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CRLX030A2211
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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