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Heart FailurePhase 3NCT00403910

Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study

A Phase 3 study testing Canrenone in people with Heart Failure, run by Heart Care Foundation at 45 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The RALES study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with NYHA III or IV heart failure. This favourable effect was clearly independent from a diuretic effect. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Canrenone
How many people
500 participants
Where
45 sitesItaly
Study dates
Sep 2002to Jul 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Established diagnosis of congestive heart failure in NYHA class II
  • Left ventricular ejection fraction <= 45% measured within 6 months from enrolment
  • Stable standard heart failure therapy (if patients are on beta blocker drugs, treatment must have been started at least three months before enrolment)
  • Informed consent (obtained prior of any study procedures)

Who cannot join

  • Age <18 and >80
  • Serum creatinine level > 2.5 mg per deciliter
  • Serum potassium level > 5.0 mmol per liter
  • Valvular heart disease amenable to surgical treatment
  • Congenital heart disease
  • Unstable angina and/or acute myocardial infarction and/or coronary revascularization procedure within three months before enrolment
Show all 18Show fewer
  • Intravenous therapy with inotropic drugs within three months before enrolment
  • History of resuscitated ventricular fibrillation or tachycardia, unless these occurred within 24 hours of an acute myocardial infarction or the subject has an implanted an automatic cardioverter defibrillator
  • Chronic active hepatitis or cirrhosis
  • Malignant neoplasm or any life threatening non cardiac disease
  • History of hypersensitivity to study drug
  • Pregnancy or lactating or childbearing age women who are not protected by an accepted method of contraception
  • History of drug or alcohol abuse
  • Legal incapacity and/or other circumstances rending the patient unable to understand the nature, scope and possible consequences of the study.
  • Evidence of uncooperative attitude
  • Any condition other than heart failure that does not permit an optimal participation to the trial
  • Participation to other RCTs during the last 3 months
  • Treatment with: Lithium salts, Potassium sparing diuretics, oral positive inotropic drugs or any investigational drug

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Italy45 sites

  • Presidio GM Lancisi

    Ancona

  • Az Ospedaliera Giuseppe Moscati

    Avellino

  • Presidio Ospedaliero Moscati

    Aversa (CE)

  • Ospedale Monsignor Angelo R di Miccoli

    Barletta (BA)

  • Ospedali Riuniti

    Bergamo

  • Cardiologia Tiarini Corticella

    Bologna

  • Ospedale Generale Provinciale

    Bolzano

  • Az Osp G Brotzu - S Michele

    Cagliari

  • Az Ospedaliera S Anna e S Sebastiano

    Caserta

  • Ospedale San Raffaele G Giglio

    Cefalù (PA)

  • Ospedale Civile San Giuseppe

    Empoli (FI)

  • Ospedale Santa Maria del Prato

    Feltre

  • Ospedale Civile Dario Camberlingo

    Francavilla Fontana (BR)

  • Az Osp-Univ San Martino

    Genova

  • Ospedale Civile

    Ivrea

  • Ospedale Fatebenefratelli

    Milan

  • Hepseria Hospital Modena SPA

    Modena

  • Ospedale Policlinico

    Modena

  • Fondazione Evangelica Betania

    Naples

  • Ospedale V Cervello

    Palermo

  • Presidio Ospedaliero di Passirana

    Passirana Rho (MI)

  • Ospedale Policlinico S Matteo IRCCS

    Pavia

  • Azienda Ospedaliera di Perugia

    Perugia

  • Ospedale della val di nievole

    Pescia (PT)

  • Azienda CREAS - IFC CNR San Cartaldo

    Pisa

  • Ospedale Generale Provinciale Lotti

    Pontedera (PT)

  • Ospedale Civile

    Ragusa (RG)

  • Ospedale Infermi

    Rimini

  • Ospedale San Camillo

    Roma

  • Ospedale Sant'Andrea

    Roma

  • Ospedale Santo Spirito

    Roma

  • Policlinico Luigi di Liegro

    Roma

  • Az Osp San Giovanni di Dio e Ruggi d'Aragona

    Salerno

  • Ospedale G Fra Cristoforo

    San Bonifacio (VR)

  • Ospedale casa Sollievo della Sofferenza

    San Giovanni Rotondo (FG)

  • Presidio Ospedaliero di Saronno

    Saronno

  • Ospedale San Bartolomeo

    Sarzana (GE)

  • Ospedale SS Annunziata

    Sassari

  • IRCCS Policlinico Multimedica

    Sesto San Giovanni

  • Fondazione S Maugeri Clinica del Lavoro

    Telese Terme (BN)

  • Ospedale Cardinale Panico

    Tricase (LE)

  • Az Osp-Univ Ospdali Riuniti

    Trieste

  • Ospedale San Luca

    Vallo Della Lucania (SA)

  • Ospedale di Circolo e Fondazione Macchi

    Varese

  • Ospedali Civili Riuniti

    Venezia

Other trials in Italy

About this study

Official title: Phase 3 Study Of Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure

The RALES study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with NYHA III or IV heart failure. This favourable effect was clearly independent from a diuretic effect. Antialdosterone drugs may be effective because they opposes the effects of aldosterone on sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor function and vascular compliance. Antialdosterone treatment may also antagonize the effect of aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a marker of cardiac fibrosis synthesis showed an independent negative correlation with survival and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in patients with mild heart failure assuming standard therapy.

Read the detailed description

The protocol is sponsored by and independent organization and partially supported by Therabel

Conditions
Heart Failure
Being tested
Canrenone
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanrenoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in echocardiographic left ventricular diastolic volume

Secondary outcomes (6)

  1. Changes in left ventricular systolic volume

  2. Changes in ejection fraction

  3. Changes in NYHA class

  4. cardiac mortality

  5. hospitalization for cardiac causes

  6. combination of cardiac mortality hospitalizations for cardiac causes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2006 (estimated)
  2. Study startSep 2002
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403910
Sponsor's protocol ID
17
Status last verified
Apr 2009
First submitted
24 Nov 2006
Last updated
3 Feb 2021
Results posted
No

Publications

  • Cacciatore G, Boccanelli A, Mureddu GF, Maggioni AP, Latini R, Masson S, de Simone G; Investigatori dell' Area In-CHF. [The AREA IN-CHF trial (antiremodeling effect of aldosterone receptors blockade with canrenone in mild chronic heart failure): rationale and design]. Ital Heart J. 2005 May;6 Suppl 1:66S-74S. Italian.

    PubMed 15945301

  • de Simone G, Chinali M, Mureddu GF, Cacciatore G, Lucci D, Latini R, Masson S, Vanasia M, Maggioni AP, Boccanelli A; AREA-in-CHF Investigators. Effect of canrenone on left ventricular mechanics in patients with mild systolic heart failure and metabolic syndrome: the AREA-in-CHF study. Nutr Metab Cardiovasc Dis. 2011 Oct;21(10):783-91. doi: 10.1016/j.numecd.2010.02.012. Epub 2010 Jun 17.

    PubMed 21939839

  • Clemenza F, Masson S, Conaldi PG, Di Carlo D, Boccanelli A, Mureddu GF, Gonzini L, Lucci D, Maggioni AP, Di Lenarda A, Nicolis EB, Vanasia M, Latini R; AREA IN-CHF Investigators. Galectin-3 and the Mineralocorticoid Receptor Antagonist Canrenone in Mild Heart Failure. Circ J. 2017 Sep 25;81(10):1543-1546. doi: 10.1253/circj.CJ-17-0656. Epub 2017 Aug 31.

    PubMed 28855452

  • Boccanelli A, Mureddu GF, Cacciatore G, Clemenza F, Di Lenarda A, Gavazzi A, Porcu M, Latini R, Lucci D, Maggioni AP, Masson S, Vanasia M, de Simone G; AREA IN-CHF Investigators. Anti-remodelling effect of canrenone in patients with mild chronic heart failure (AREA IN-CHF study): final results. Eur J Heart Fail. 2009 Jan;11(1):68-76. doi: 10.1093/eurjhf/hfn015.

    PubMed 19147459

  • Boccanelli A, Cacciatore G, Mureddu GF, de Simone G, Clemenza F, De Maria R, Di Lenarda A, Gavazzi A, Latini R, Masson S, Porcu M, Vanasia M, Gonzini L, Maggioni AP. Baseline characteristics of patients recruited in the AREA IN-CHF study (Antiremodelling Effect of Aldosterone Receptors Blockade with Canrenone in Mild Chronic Heart Failure). J Cardiovasc Med (Hagerstown). 2007 Sep;8(9):683-91. doi: 10.2459/JCM.0b013e3281053a9a.

    PubMed 17700397

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canrenone in people with Heart Failure, run by Heart Care Foundation at 45 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in echocardiographic left ventricular diastolic volume. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403910, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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