NCT03551548

Brief Summary

Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral surgery. Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay). Primary objective: To establish whether pre-operative administration of spironolactone leads to a reduction in POAF incidence occurring from randomization and within 5 days after surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR without heart failure. Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2019

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 5, 2019

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

May 29, 2018

Last Update Submit

March 2, 2019

Conditions

Cardiac SurgeryAtrial FibrillationAldosterone Blockade

Outcome Measures

Primary Outcomes (1)

  • POAF occurrence

    the occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay).

    5 days

Secondary Outcomes (8)

  • Post-operative AF occurrence from cardiac surgery and within 5 days after CABG surgery (+/- AVR),

    5 days

  • Evaluation of perioperative myocardial injury within 2 days after surgery, as assessed by serial measurements of the cardiac troponin I concentration at day 0 immediately after surgery, day 1 and 2 after surgery,

    2 days

  • Occurrence of major cardiovascular events and death (death from any cause, stroke, heart failure, myocardial infarction) occurring within 30 days after surgery,

    30 days

  • Duration of ICU and hospital stay,

    30 days

  • Need for readmission,

    30 days

  • +3 more secondary outcomes

Other Outcomes (1)

  • Ability of the Aldoscore to predict POAF and cardiovascular complications and mortality.

    30 days

Study Arms (2)

Reference treatment

PLACEBO COMPARATOR
Drug: Placebo oral capsule

experimental treatment

EXPERIMENTAL

Spironolactone 25 mg

Drug: Spironolactone 25mg

Interventions

Spironolactone 25mgDRUG

25 mg oral spironolactone once daily on top of standard therapy, started 14 ± 4 days before cardiac surgery and continued during 30 days after surgery.

experimental treatment
Placebo oral capsuleDRUG

oral placebo once daily on top of standard therapy, started 14 ± 4 days before cardiac surgery and continued during 30 days after surgery.

Reference treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female; Age ≥ 18 years
  • On-pump elective CABG surgery ± AVR
  • In sinus rhythm
  • Patient signed consent
  • Willing to comply with scheduled visits, as outlined in the protocol
  • French nationality
  • Recipients of the social security regime

You may not qualify if:

  • Contraindications to spironolactone therapy: intolerance, hyperkalemia (\>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) \< 30 ml/min. Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min), Severe liver dysfunction (Child-Pugh Class 3), patients treated by other potassium sparing medication (except in case of hypokalemia).
  • Patients treated by MRA treatment (spironolactone or eplerenone)
  • LVEF \< 50% obtained within 6 months prior to V0
  • Mitral valve surgery associated to the CABG
  • Off-pump beating or emergent/urgent CABG
  • History of AF or another atrial arrhythmia
  • Presence of antiarrhythmic medication (other than β-blockers)
  • Previous heart surgery and heart transplant recipient
  • Unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock
  • Patients included or planning to be included in another medical research protocol
  • Patients unable to complete the protocol follow-up
  • Pregnant or nursing women
  • Adults with protective measures (curatorship or tutorship or safeguarding justice or juridical protection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Caen

Caen, Normandy, 14000, France

RECRUITING

Gaillard

Caen, Normandy, 14000, France

NOT YET RECRUITING

Related Publications (1)

  • Alexandre J, Ollitrault P, Fischer MO, Fellahi JL, Rozec B, Cholley B, Dolladille C, Chequel M, Allouche S, Legallois D, Saplacan V, Buklas D, Beygui F, Parienti JJ, Milliez P. Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial. Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

    PMID: 31174055DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Cathy Gaillard

CONTACT

+33231065349gaillard-c@chu-caen.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 11, 2018

Study Start

February 26, 2019

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

March 5, 2019

Record last verified: 2018-05

Locations

FR(2)