Clinical Trials Register

Summary
EudraCT Number:	2014-002257-19
Sponsor's Protocol Code Number:	CARDIORYC-2014-001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-02-16
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-002257-19

A.3

Full title of the trial

Single-center, randomized, open, controlled by echocardiography to evaluate the effect of serelaxina in the functioning of the right ventricle and its potential in the prognosis of acute heart failure impact.

Estudio monocéntrico, aleatorizado, abierto, controlado para evaluar mediante ecocardiografía el efecto de serelaxina en el funcionamiento del ventrículo derecho y su impacto potencial en el pronóstico de la insuficiencia cardíaca aguda.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to evaluate the effect of using ecocargiografia serelaxina in the functioning of the right ventricle.

Estudio para evaluar mediante ecocargiografia el efecto de serelaxina en el funcionamiento del ventriculo derecho.

A.3.2

Name or abbreviated title of the trial where available

ECO-RELAX

A.4.1

Sponsor's protocol code number

CARDIORYC-2014-001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Ramón y Cajal
B.5.2	Functional name of contact point	Dr. Jose Luis Zamorano Gómez
B.5.3	Address:
B.5.3.1	Street Address	Carretera de Colmenar Km 9,100
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28034
B.5.3.4	Country	Spain
B.5.4	Telephone number	3491336 85 15
B.5.6	E-mail	zamorano@secardiologia.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Serelaxina
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SERELAXIN
D.3.9.2	Current sponsor code	RLX030
D.3.9.4	EV Substance Code	SUB119779
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ICA hospitalized patients with high normal blood pressure, and mild to moderate renal failure at the time of selection

Pacientes hospitalizados por ICA, con presión arterial normal a elevada, e insuficiencia renal leve a moderada en el momento de la selección.

E.1.1.1

Medical condition in easily understood language

Patients with acute heart failure

Pacientes con insuficiencia cardíaca aguda

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10007648
E.1.2	Term	Cardiovascular disease, unspecified
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Clarify the pathophysiological mechanism that could contribute to a better outcome in patients treated with serelaxina, determining changes in the function of the right ventricle (RV) by echocardiography compared with patients receiving standard therapy only.

Esclarecer el mecanismo fisiopatológico que podría contribuir a un mejor resultado en pacientes tratados con serelaxina, determinando los cambios en la función del ventrículo derecho (VD) mediante ecocardiografía, en comparación con los pacientes que reciben solamente la terapia de referencia.

E.2.2

Secondary objectives of the trial

Assessing changes in systolic pulmonary artery pressure (PSAP) after treatment with serelaxina compared to patients receiving only the reference therapy.
Evaluating changes in the size and volume of the right ventricle and atrium serelaxina after treatment compared with patients receiving only reference therapy.
Evaluate changes in systolic and diastolic left ventricular (LV) after treatment with serelaxina compared to patients receiving only standard therapy.
Assessing changes in BNP levels and troponin I after treatment with serelaxina compared to patients receiving only the reference therapy.
To evaluate the incidence of adverse events (AEs) and serious adverse events (AAGS) in the two study groups

Evaluar los cambios en la presión sistólica de la arteria pulmonar (PSAP) después del tratamiento con serelaxina en comparación con los pacientes que reciben solamente la terapia de referencia.
Evaluar los cambios en el tamaño y volúmenes del ventrículo y aurícula derechos después del tratamiento con serelaxina en comparación con pacientes que reciben solamente la terapia de referencia.
Evaluar los cambios producidos en la función sistólica y diastólica del ventrículo izquierdo (VI) después del tratamiento con serelaxina en comparación con pacientes que reciben solamente la terapia de referencia.
Evaluar los cambios en los niveles de BNP y troponina I después del tratamiento con serelaxina en comparación con los pacientes que reciben solamente la terapia de referencia.
Evaluar la incidencia de acontecimientos adversos (AAs) y acontecimientos adversos graves (AAGs), en los dos grupos de estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who have signed the informed consent to participate in the study.

2. Systolic blood pressure> 125 mmHg and impaired renal function, defined as an estimated glomerular filtration rate (eGFR) between the presentation in the hospital and randomization of > or = 30 and < or = 75 ml / min / 1.73m2, calculated using the equation simplified Modification of Diet in Renal disease (sMDRD)

3. Patients admitted for AHF.

4. can start serelaxina infusion within 16 hours of presentation to hospital.

5. Have received intravenous furosemide at least 40 mg (or equivalent) at any time between admission to the emergency department and the beginning of the selection for the study.

1.Pacientes que hayan firmado el consentimiento informado para participar en el estudio.

2.Presión arterial sistólica > 125 mmHg y función renal alterada, definida como una tasa de filtrado glomerular estimada (TFGe) entre la presentación en el hospital y la aleatorización de > ó = 30 y < ó = 75 ml/min/1,73m2, calculada utilizando la ecuación de la Modificación simplificada de la Dieta en Enfermedad Renal (sMDRD)

3.Pacientes ingresados por ICA.

4.Que se pueda empezar la infusión de serelaxina dentro de las 16 horas de la presentación en el hospital.

5.Haber recibido furosemida intravenosa de al menos 40 mg (o equivalente) en cualquier momento entre el ingreso en el servicio de urgencias y el comienzo de la selección para el estudio.

E.4

Principal exclusion criteria

1. Temperature> 38.5 ° C (oral or equivalent) or sepsis or active infection that requires antibiotic treatment iv

2. Dyspnea mainly due to noncardiac causes.

3. Clinical evidence of acute currently or within 30 days prior to enrollment coronary syndrome.

4. Significant tract obstruction greets the left ventricle, such as hypertrophic obstructive cardiomyopathy or severe aortic stenosis (ie, aortic valve area <1.0 cm2 or mean gradient> 50 mmHg in previous or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.

5. Current treatment (within 2 hours prior to screening) or planned (until the end of the infusion of study medication) with any iv vasoactive therapy, including vasodilators, positive inotropes and vasopressors or mechanical support, except for iv furosemide (or equivalent), or nitrates i.v. at a dose of < or = 0.1 mg / kg / hour if the patient has a systolic BP> 150 mmHg in the selection.

6. ICA due to major arrhythmias (including any of the following: sustained ventricular tachycardia, bradycardia <45 beats per minute or fibrillation / atrial flutter with sustained ventricular response> 130 beats per minute), acute myocarditis or hypertrophic obstructive cardiomyopathy, constrictive or restrictive.

7. Patients with severely impaired renal function defined as an eGFR <25 ml / min / 1.73m2, calculated using equation sMDRD.

8. Receiver of any organ or patient with anticipated / planned for next year transplant.

9. major or important in the 30 days prior to screening neurological event Surgery.

10. Hypersensitivity to serelaxina or similar substances or any other excipient

1.Temperatura > 38,5 ºC (oral o equivalente) o sepsis o infección activa que precise tratamiento antimicrobiano i.v.

2.Disnea principalmente debida a causas no cardíacas.

3.Evidencia clínica de síndrome coronario agudo actualmente o en los 30 días previos al reclutamiento.

4.Obstrucción significativa del conducto de saluda del ventrículo izquierdo, tales como miocardiopatía hipertrófica obstructiva o estenosis aórtica severa (es decir, área valvular aórtica < 1,0 cm2 o gradiente medio > 50 mmHg en ecocardiograma previo o actual), regurgitación aórtica severa y estenosis mitral severa.

5.Tratamiento actual (en las 2 horas previas a la selección) o planificado (hasta la finalización de la infusión de la medicación de estudio) con cualquier terapia vasoactiva i.v., incluidos vasodilatadores, fármacos inotrópicos positivos y vasopresores, o soporte mecánico, excepto por furosemida i.v. (o equivalente), o nitratos i.v. a una dosis de < ó = 0,1 mg/kg/hora si el paciente tiene una PA sistólica > 150 mmHg en la selección.

6.ICA debida a arritmias importantes (que incluyan cualquiera de las siguientes: taquicardia ventricular sostenida, bradicardia < 45 latidos por minuto, o fibrilación/aleteo auricular con respuesta ventricular sostenida de > 130 latidos por minuto), miocarditis aguda o miocardiopatía hipertrófica obstructiva, restrictiva o constrictiva.

7.Pacientes con alteración severa de la función renal definida como una TFGe < 25 ml/min/1,73m2, calculada utilizando la ecuación de sMDRD.

8.Receptor de cualquier trasplante de órgano o paciente con trasplante anticipado/planeado para el siguiente año.

9.Cirugía mayor o acontecimiento neurológico importante en los 30 días previos a la selección.

10.Hipersensibilidad conocida a serelaxina o substancias similares o a cualquier otro excipiente.

E.5 End points

E.5.1

Primary end point(s)

The main variable is the difference between TAPSE values (mm) at baseline and 8-12 hours post treatment and the difference between baseline values TAPSE After a week follow-up

La variable principal será la diferencia entre los valores de TAPSE (mm) basales y a las 8-12 horas del tratamiento así como la diferencia entre los valores de TAPSE basales y al cabo de una semana de seguimiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

17 months

17 meses

E.5.2

Secondary end point(s)

Changes in systolic pulmonary artery pressure (PASP)
Changes in the size and volume of the RV and right atrium (RA)
Changes in systolic and diastolic LV function
Changes in levels of BNP and troponin.
Hospital readmissions and deaths

Cambios en la presión sistólica de la arteria pulmonar (PSAP)
Cambios en el tamaño y volúmenes del VD y la aurícula derecha (AD)
Cambios en la función sistólica y diastólica del VI
Cambios en los niveles de BNP y troponina.
Readmisiones hospitalarias y muertes

E.5.2.1

Timepoint(s) of evaluation of this end point

17 months

17 meses

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia de referencia

Reference therapy

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LPLV (last patient last visit)

LPLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not plans

No existen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-04-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-29

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
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