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Register:	EUCTR
Last refreshed on:	5 June 2018
Main ID:	EUCTR2013-002513-35-SI
Date of registration:	14/05/2014
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharma Services AG
Public title:	Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.
Scientific title:	A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients. - RELAX AHF_Pan EU
Date of first enrolment:	19/06/2014
Target sample size:	2685
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002513-35
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Standard of Care Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Belgium	Bulgaria	Croatia	Czech Republic	Denmark	Estonia	Finland
France	Germany	Greece	Hungary	Iceland	Italy	Latvia	Lithuania
Poland	Portugal	Romania	Russian Federation	Serbia	Slovakia	Slovenia	Spain
Switzerland	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- Systolic blood pressure =125 mmHg
- Admitted for AHF
- Furosemide at any time between admission and the start of screening
- eGFR on admission: =30 and =75 mL/min/1.73 m2

Other protocol-defined inclusion criteria may apply.
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 617
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2068

Exclusion criteria:
- Dyspnea (non-cardiac causes)
- T >38.5°C
- Clinical evidence of acute coronary syndrome
- AHF due to arrhythmias, acute myocarditis or cardiomyopathy

Other protocol-defined exclusion criteria may apply.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute heart failure

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

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-

Primary Outcome(s)

Primary end point(s): - Time to Worsening of heart failure (WHF) requiring rescue therapy or all cause death through Day 5 post randomization.
- Time will be computed in hours from randomization to the earlier of the events.

Secondary Objective: - Evaluate the Time to WHF requiring rescue therapy/all cause death/readmission.
- Evaluate the percentage of patients with persistent signs or symptoms of HF/ non-improvement
- Evaluate the percentage of patients with renal deterioration.
- Evaluate the length of stay.

Main Objective: Evaluate the time to Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.

Timepoint(s) of evaluation of this end point: Through Day 5 post randomization

Secondary Outcome(s)

Secondary end point(s): - Time to Worsening of heart failure requiring rescue therapy as defined in the primary endpoint, or all cause of death or readmission for heart failure. Time will be computed in hours from randomization to the earlier of the events.
- Percentage of patients with persistent symptoms or signs of Heart Failure / not showing an improvement versus baseline conditions (persisting need of IV therapy for HF).
- Percentage of patients with renal deterioration, defined as = 0.3 mg/dL increase in serum creatinine.
- Lengh of Stay (LOS). It will be defined as hours from the index hospitalization and the discharge.

Timepoint(s) of evaluation of this end point: - All cause of death or readmission for heart failure and or renal failure will be evaluated through Day 14 post randomization.
- Persistent symptoms or signs of HF / no improvement will be evaluated at 6, 12, 24 and 48 hours from start of drug infusion, daily through index hospitalization and at Day 5.
- Renal deterioration will be evaluated at 24 and 48 hours from start of drug infusion, at Day 5 and at Day 14.
- Length of stay will be evaluated through Day 30 post randomization.

Secondary ID(s)

2013-002513-35-GB

CRLX030A3301

Source(s) of Monetary Support

Novartis Pharma Services AG

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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