Clinical Trials Register

Summary
EudraCT Number:	2011-003611-37
Sponsor's Protocol Code Number:	PREVENT-CINHF
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003611-37

A.3

Full title of the trial

PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: hydratation vs carbonates to prevent Contrast-Induced Nephropathy in patients undergoing coronary angiography or intervention at risk for Heart Failure (PREVENT-CIN HF). A prospective randomized trial.

Prevenzione delle complicanze periprocedurali cardiache e vascolari in pazienti sottoposti ad angiografia o angioplastica coronarica: idratazione vs carbonati nella prevenzione dell'insufficienza renale da mezzo di contrasto in pazienti sottoposti ad angiografia o angioplastica coronarica a rischio di scompenso cardiaco (PREVENT-CINHF). Studio prospettico randomizzato.

A.3.1

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

Comparison between 2 different hydration strategies (saline solution vs carbonati) for the prevention of contrast induced nephropaty in patients at risk for heart failure undergoing coronary angiography or intervention

Confronto tra 2 differenti strategie di idratazione (soluzione fisiologica vs bicarbonati) per la prevenzione dell'insufficienza renale acuta da mezzo di contrasto nei pazienti ad alto riscio di scompenso cardiaco sottoposti a procedure di angiografia e/o angioplastica coronarica

A.3.2

Name or abbreviated title of the trial where available

PREVENT-CINHF

A.4.1

Sponsor's protocol code number

PREVENT-CINHF

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	AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA
B.1.3.4	Country	Italy
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	Azienda Ospedaliero-Universitaria Maggiore della Carita' di Novara
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliero-Universitaria Maggiore della Carita' di Novara
B.5.2	Functional name of contact point	Prof. Giuseppe De Luca
B.5.3	Address:
B.5.3.1	Street Address	Corso Mazzini 18
B.5.3.2	Town/ city	Novara
B.5.3.3	Post code	28100
B.5.3.4	Country	Italy
B.5.4	Telephone number	03213733294
B.5.5	Fax number	03213733407
B.5.6	E-mail	p.de_luca@libero.it

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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	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	SODIUM BICARBONATE
D.3.9.1	CAS number	144-55-8
D.3.9.4	EV Substance Code	SUB12643MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	140
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients undergoing coronary angiography or angioplasty

Pazienti sottoposti a coronarografia o angioplastica coronarica

E.1.1.1

Medical condition in easily understood language

patients with indication to undergo coronary angiography or angioplasty

Pazienti con indicazione secondo la pratica clinica ad eseguire coronarografia e/o angioplastica percutanea

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10007541
E.1.2	Term	Cardiac disorders
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to demonstrate the superiority of an experimental hydration “CARBONATI” (154 mEq/l in dextrose and water received 3 ml/kg for 1h before contrast exposure followed by an infusion of 1 ml/kg/h for 6h after the procedure) versus isotonic saline solution (standard hydratation) received 0,5 ml/kg/h sodium chloride intravenously for 12 h before and after the procedure, in patients with high risk of acute heart failure ad high risk to develop contrast induced nephropaty, who undergoing coronary angiography, followed or not by coronary revascularization.

dimostrare la superiorità di un’idratazione sperimentale a base di “CARBONATI” (154mEq/L di bicarbonato di sodio in destrosio ed acqua ad una dose di 3ml/kg/h per un’ora prima della procedura e di 1ml/kg/h durante e per 6h dopo procedura) rispetto al protocollo standard di idratazione utilizzato in pazienti ad alto rischio di scompenso cardiaco acuto (soluzione fisiologica 0,9% 0,5ml/kg/ora) in pazienti ad elevato rischio di sviluppare nefropatia da contrasto che vengono sottoposti a procedure di angiografia coronarica seguite o meno da rivascolarizzazione coronarica percutanea.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Consecutive patients undergoing coronary angiography, followed or not by coronary revascularization, at Cath Lab of U.O. of Universitary Cardiology “AOU Maggiore della Carità”, Novara.
• An estimated glomerular filtration rate (GFR) of 60 mL/min or less (calculated by applying the Cockroft-Gault formula) before undergoing coronary angiography.
• An estimated ejection fraction<40% (transthoracic echocardiogram).

• Severe mitro-aortic valve disease estimated by transthoracic echocardiogram also in the presence of an ejection fraction >40%.
• Recent episode af acute pulmonary edema.

• Pazienti consecutivi sottoposti a procedura di angiografia coronarica seguita o meno da angioplastica, presso il Laboratorio di Emodinamica dell’ U.O. di Cardiologia Universitaria dell’ Azienda Ospedaliero-Universitaria “Maggiore della Carità” di Novara.
• Presenza di una ridotta funzione renale con clearance della creatinina < 60 ml/min (calcolata secondo il metodo di Cockroft-Gault) pre-esistente alla procedura angiografica.
• Frazione di eiezione inferiore al 40% stimata in corso di esame ecocardiografico transtoracico.
• Valvulopatia mitralica o aortica severa, evidenziabile all’ecocardiogramma transtoracico, anche in presenza di funzionalità sistolica globale conservata (>40%).
• Recente episodio di edema polmonare acuto.

E.4

Principal exclusion criteria

• Inability to obtain consent.
• Age lower than 18 years old.
• Pregnancy.
• Coronary angiography/or revascularisation in emergency.
• Serious comorbility (shock, cardiac arrest, trauma, etc.).
• An estimated ejection fraction >40% (transthoracic echocardiogram).
• Hystory of contrast intolerance.
• Kidney transplant.
• Periprocedural complications within 48h after the procedure.

• Incapacità a fornire da parte del paziente un consenso informato scritto.
• Età del paziente inferiore ai 18 anni.
• Paziente in stato di gravidanza.
• Procedura angiografica o di angioplastica eseguita in emergenza.
• Comorbilità acuta grave (shock di qualsiasi origine, recente arresto cardiocircolatorio, trauma, etc.).
• Funzione sistolica globale maggiore del 40% evidenziabile all’esame ecografico transtoracico.
• Storia di precedente intolleranza a mezzo di contrasto.
• Trapianto renale.
• Pazienti che, entro 48 ore dalla manovra, abbiano sviluppato complicanze acute periprocedurali quali dissecazione arteriosa, infarto miocardico acuto, emorragia grave, sepsi, arresto cardiaco, shock, etc.).

E.5 End points

E.5.1

Primary end point(s)

Incidence of contrast-induced nephropaty defined as an increases in serum creatinine concentration either at least 0.5 mg/dl or 25% from baseline within 48 hours after coronary angiography.

Incidenza di insufficienza renale acuta da m.d.c. definita come aumento assoluto della creatinina di 0.5 o un aumento relativo del 25% rispetto al valore basale.

E.5.1.1

Timepoint(s) of evaluation of this end point

48h after procedure

A massimo 48h dalla procedura

E.5.2

Secondary end point(s)

Incidence of acute heart failure (pulmunary edema)

Incidenza di scompenso cardiaco acuto (edema polmonare)

E.5.2.1

Timepoint(s) of evaluation of this end point

In 24h from the beginning of hydration

Entro 24h dall'avvio dell'idratazione

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in 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

LVLS

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

240

F.4.2

For a multinational trial

F.4.2.1

In the EEA

240

F.4.2.2

In the whole clinical trial

240

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)

No one

Nessun tipo di trattamento o assistenza al termine dello studio

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

2011-08-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-28

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

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