Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2013-002513-35-PT
• Date of registration: 14/02/2014
• 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: 14/04/2014
• Target sample size: 3183
• 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, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Farma - Produtos Farmacêuticos, S.A.

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Farma - Produtos Farmacêuticos, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female = 18 years of age with body weight = 40 Kg and = 160 Kg
- Systolic blood pressure =125 mmHg ate the beggining of the screening period (after ICF signature) and at the end of the screening period (prior to randomization)
- Admitted for AHF: Persistent dyspnea at rest or with minimal exertion, Pulmonary congestion assessed through physical examination and chest X-Ray
- Furosemide at any time between admission and the start of screening
- eGFR on admission: =25 and =75 mL/min/1.73 m2
- BNP =500 pg/mL or N-terminal pro b-type natriuretic peptide (NT-proBNP)=2,000 pg/mL

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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2483

Exclusion criteria:
- Dyspnea (non-cardiac causes) such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret the primary cause of dyspnea.
- T >38.5°C
- Clinical evidence of acute coronary syndrome
- AHF due to arrhythmias, acute myocarditis or cardiomyopathy
- Known history of respiratory disorders requiring the daily use of IV steroids (does not include inhaled or oral steroids) at least 2 months prior to randomization; need for intubation or the current use of IV steroids for COPD
- Patients with systolic blood pressure > 180 mmHg at end of screening or persistent heart rate >130 bpm
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year

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)

Secondary Objective: - Evaluate the Time to in-hospital 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 in-hospital Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.

Primary end point(s): - Time to in-hospital 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.

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

Secondary Outcome(s)

Secondary end point(s): - Time to in-hospital 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 through 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)

CRLX030A3301

2013-002513-35-GB

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 10/05/2018
• Date Completed: 25/04/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-002513-35/results