Aldosterone Blockade Early After Acute Myocardial Infarction (ALBATROSS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01059136
First received: January 28, 2010
Last updated: May 30, 2014
Last verified: February 2014

January 28, 2010
May 30, 2014
February 2010
August 2014   (final data collection date for primary outcome measure)
The 6 month rate of the composite of death, resuscitated cardiac arrest, potentially lethal ventricular arrhythmia, indication for implantable cardioversion device, occurrence or aggravation of heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01059136 on ClinicalTrials.gov Archive Site
  • Any of the criteria of the primary endpoint [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • primary endpoint+ myocardial infarction+stroke cardiovascular death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • death + resuscitated cardiac arrest [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death+resuscitated cardiac arrest+ventricular arrhythmia+indication for implantable defibrillator device [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • death+heart failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute renal failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • primary endpoint [ Time Frame: hospital discharge and 30 days ] [ Designated as safety issue: Yes ]
  • rate of hyperkaliemia (> 5.5 mmol.l-1) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Aldosterone Blockade Early After Acute Myocardial Infarction
Aldosterone Lethal Effects Blocked in AMI Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up: THE ALBATROSS TRIAL

Study hypothesis : An early blockade of aldosterone receptors initiated at the first medical contact after acute myocardial infarction may reduce major cardiovascular events within 6 months after the occurrence of the myocardial infarction.

Primary efficacy criterion : The 6 month rate of the composite of death, resuscitated cardiac arrest, potentially lethal ventricular arrhythmia, indication for implantation of an implantable cardioversion device, occurrence or aggravation of heart failure.

Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon as possible within 72 hours after the onset of acute myocardial infarction on top of standard therapy, compared to standard therapy alone, with or without reperfusion therapy.

Study design : Prospective, multi-centre randomised, open labeled with 2 parallel study arms.

Rational :The blockade of the renin-angiotensin-aldosterone (RAA) pathway by angiotensin conversion enzyme inhibitors (ACEI) is one corner stone in the management of heart failure as well as the management of ischemic heart disease, especially after acute myocardial infarctionHigh plasma aldosterone levels have been associated with both direct and indirect toxic effects on myocardium. ACEIs are associated with partial and temporary reduction of plasma aldosterone levels.The RALES randomized controlled trial has shown a reduction of mortality associated with the use of the selective aldosterone receptor blocker spironolactone, on top of standard therapy including ACEIs in the setting of NYHA 3-4 chronic heart failure. The EPHESUS randomized controlled trial has shown a reduction of mortality associated with the use of another selective aldosterone receptor blocker Eplerenone, initiated 3 to 14 days after acute myocardial infarction complicated by clinical heart failure and left ventricular ejection fraction < 40%.Both previous studies have also reported a rapid reduction of global and arrhythmia-related mortality, within 30 days after the initiation of the medication.Such benefit has been reported after delayed initiation of aldosterone blocked, while aldosterone is at its highest level at presentation after acute myocardial infarction, with a rapid decrease within days after admission. Furthermore high aldosterone levels on admission are associated with adverse outcome independent of heart failure.

The ALBATROSS trial :Hypothesis: An early blockade of aldosterone receptors initiated at the first medical contact after acute myocardial infarction may reduce major cardiovascular events within 6 months after the occurrence of the myocardial infarction.

Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon as possible within 72 hours after the onset of acute myocardial infarction on top of standard therapy, compared to standard therapy alone, with or without reperfusion therapy.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
Drug: Spironolactone
Unique 200mg IV dose of Potassium Canrenoate followed by 25 mg daily oral dose of Spironolactone for 6 months
Other Name: Spironolactone
  • Experimental: 1:Spironolactone
    Aldosterone blockade on top of standard therapy
    Intervention: Drug: Spironolactone
  • No Intervention: 2:Standard therapy
    Standard therapy
Beygui F, Vicaut E, Ecollan P, Machecourt J, Van Belle E, Zannad F, Montalescot G. Rationale for an early aldosterone blockade in acute myocardial infarction and design of the ALBATROSS trial. Am Heart J. 2010 Oct;160(4):642-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1600
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥ 18 ans
  2. Ischemic symptom of ≥ 20 minutes
  3. Randomization within 72 hours after symptom onset
  4. Electrocardiogram or biological evidence of myocardial infarction:

    • ST segment elevation ≥ 2 mm in ≥ 2 adjacent precordial derivations
    • ST segment elevation ≥ 1 mm in ≥ 2 adjacent peripheral derivations
    • New left bundle branch block
    • New significant Q wave in ≥ 2 adjacent peripheral derivations
    • Troponin levels ≥3 times upper local limit of normal values and Thrombolysis In Myocardial Infarction (TIMI) non-ST elevation myocardial infarction risk score ≥ 3.
  5. Patients with health insurance
  6. Written informed consent obtained from:

    1. - the patient
    2. -A member of the family or the person of confidence if the patient is unable to provide informed consent

Exclusion Criteria:

  1. Contraindication or known intolerance to study drugs
  2. Patients already treated by aldosterone blockers for diseases other than systemic hypertension (e.g. primary hyperaldosteronism)
  3. Hyperkaliemia >5.5 mmol/l at the time of randomization
  4. Renal function impairment :Plasma creatinin level > 220 µmol/l and/or Creatinin clearance 30 ml/min
  5. Severe liver deficiency (Child-Pugh Class 3)
  6. Pregnant or breast feeding women, or women desiring pregnancy within 6 months after randomization
  7. Patients already included in another biomedical intervention trial
  8. Life expectancy < 1 year
  9. Cardiac arrest lasting (ECM) >10 minutes prior to randomization
  10. Patient unable or unwilling to comply with the treatment or the follow-up visits
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01059136
P071216
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Farzin BEYGUI, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP