Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes

NCT01586442

Last updated date
Study Location
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Failure, Type 2 Diabetes, Glucose Intolerance
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female at least 18 years old.

2. Symptomatic HF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.

3. A diagnosis of 1) impaired glucose tolerance described as overnight fasting between blood glucose 5.6 and 6.9 mmol/L on two occasions; or 2) type 2 diabetes defined as overnight fasting between blood glucose of 7.0 mmol/L or more on two occasions; a HbA1c equal to or higher than 6.5% or more on two occasions; or as a history of type II diabetes treated with hypoglycemic agents.

4. LVEF equal to or lower than 40% documented by, contrast ventriculography, magnetic resonance imaging, radionuclide ventriculography or quantitative echocardiography within the previous 12 months if no cardiac event occurred since the measurement of the LVEF. The most recent measurements should be used.

5. Treatment with an optimal and stable dose of ACE inhibitor (or ARB) for at least 4 weeks prior to enrolment in the study. In addition, patients should be treated with a stable dose of beta-blockers for at least 4 weeks prior enrolment in the study. Patients incapable to tolerate bisoprolol, carvedilol or metoprolol will be allowed within the trial.

6. Informed consent must be obtained before any study specific procedures are performed

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Current treatment with a combination of an ARB, an ACE or a renin inhibitor.


2. Type 1 diabetes


3. Known intolerance or allergy to eplerenone or spironolactone, including gynecomastia
with spironolactone.


4. Estimated GFR < 30 mL/min/1.73 m2 as calculated using the MDRD equation (Appendix 1).


5. Current serum potassium higher than 5.0 mmol/L (higher than 5.0 mEq/L).


6. Current symptomatic hypotension and/or systolic B.P. < 90 mmHg.


7. Persistent systolic or diastolic hypertension (systolic > 170 mmHg or diastolic > 100
mmHg despite use of antihypertensive therapy).


8. HF secondary to any of the following conditions: hemodynamically significant primary
stenotic valvular cardiomyopathy, isolated right sided CHF, non cardiac disease (e.g.
uncorrected thyroid disease), pericardial disease, complex congenital heart disease,
myocarditis.


9. Decompensated heart failure described as hospitalization or I.V. administration of
medication in emergency room or heart failure clinic within 4 weeks (ex.: diuretics,
inotropes, vasodilatators)


10. Current treatment with insulin


11. Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.


12. Cardiac surgery within 3 months.


13. Significant liver disease (ALT x 3 times limit of normal).


14. Planned cardiac surgery expected to be performed within the next 6 months.


15. Previous heart transplant or heart transplant expected to be performed within the next
6 months.


16. Presence of any non-cardiac diseases likely to significantly shorten life expectancy
to < 1 year.


17. Pregnant or lactating women or women of childbearing potential who are not protected
from pregnancy by an accepted method of contraception, such as the oral contraceptive
pill, an intrauterine device or surgical sterilization (all women of childbearing
potential must have a negative pregnancy test before randomization).


18. Any condition that in the opinion of the investigator would jeopardize the evaluation
on efficacy or safety or be associated with poor adherence to the protocol.


19. Treatment with any investigational agent or device within 4 weeks of randomization.

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Heart Failure, Type 2 Diabetes, Glucose IntoleranceComparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes
NCT01586442
  1. Montreal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes
Official Title  ICMJE A Comparison of the Effects of Selective and Non Selective Mineralocorticoid Antagonism on Glucose Homeostasis and Lipid Profile of Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes.
Brief Summary In this proposal,the investigators will examine whether the selectivity of eplerenone for the MR will translate into a better glucose and metabolic profile compare to spironolactone in patients with HF with glucose intolerance or type 2 diabetes. In addition, the investigators will also compare the impact of these two agents on changes of concentrations of established prognostic biomarkers of neurohormonal activation and extracellular matrix turnover.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Type 2 Diabetes
  • Glucose Intolerance
Intervention  ICMJE
  • Drug: Eplerenone
    Eplerenone 25mg once daily titrated to 50 mg once daily for 4 months
    Other Name: Inspra
  • Drug: Spironolactone
    Spironolactone 12,5mg daily titrated to 25mg once daily for 16 weeks
    Other Name: Aldactone
Study Arms  ICMJE
  • Active Comparator: Spironolactone
    spironolactone 12.5mg once daily titrated to 25mg once daily
    Intervention: Drug: Spironolactone
  • Experimental: Eplerenone
    Eplerenone 25mg once daily titrated to 50mg once daily
    Intervention: Drug: Eplerenone
Publications * Korol S, White M, O'Meara E, Tournoux F, Racine N, Ducharme A, Rouleau JL, Liszkowski M, Mansour A, Jutras M, Guertin MC, Bernier M, Lavoie J, Leclair G, Neagoe PE, Chaar D, Sirois MG, de Denus S. A comparison of the effects of selective and non-selective mineralocorticoid antagonism on glucose homeostasis of heart failure patients with glucose intolerance or type II diabetes: A randomized controlled double-blind trial. Am Heart J. 2018 Oct;204:190-195. doi: 10.1016/j.ahj.2018.07.002. Epub 2018 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female at least 18 years old.
  2. Symptomatic HF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
  3. A diagnosis of 1) impaired glucose tolerance described as overnight fasting between blood glucose 5.6 and 6.9 mmol/L on two occasions; or 2) type 2 diabetes defined as overnight fasting between blood glucose of 7.0 mmol/L or more on two occasions; a HbA1c equal to or higher than 6.5% or more on two occasions; or as a history of type II diabetes treated with hypoglycemic agents.
  4. LVEF equal to or lower than 40% documented by, contrast ventriculography, magnetic resonance imaging, radionuclide ventriculography or quantitative echocardiography within the previous 12 months if no cardiac event occurred since the measurement of the LVEF. The most recent measurements should be used.
  5. Treatment with an optimal and stable dose of ACE inhibitor (or ARB) for at least 4 weeks prior to enrolment in the study. In addition, patients should be treated with a stable dose of beta-blockers for at least 4 weeks prior enrolment in the study. Patients incapable to tolerate bisoprolol, carvedilol or metoprolol will be allowed within the trial.
  6. Informed consent must be obtained before any study specific procedures are performed

Exclusion Criteria:

  1. Current treatment with a combination of an ARB, an ACE or a renin inhibitor.
  2. Type 1 diabetes
  3. Known intolerance or allergy to eplerenone or spironolactone, including gynecomastia with spironolactone.
  4. Estimated GFR < 30 mL/min/1.73 m2 as calculated using the MDRD equation (Appendix 1).
  5. Current serum potassium higher than 5.0 mmol/L (higher than 5.0 mEq/L).
  6. Current symptomatic hypotension and/or systolic B.P. < 90 mmHg.
  7. Persistent systolic or diastolic hypertension (systolic > 170 mmHg or diastolic > 100 mmHg despite use of antihypertensive therapy).
  8. HF secondary to any of the following conditions: hemodynamically significant primary stenotic valvular cardiomyopathy, isolated right sided CHF, non cardiac disease (e.g. uncorrected thyroid disease), pericardial disease, complex congenital heart disease, myocarditis.
  9. Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks (ex.: diuretics, inotropes, vasodilatators)
  10. Current treatment with insulin
  11. Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
  12. Cardiac surgery within 3 months.
  13. Significant liver disease (ALT x 3 times limit of normal).
  14. Planned cardiac surgery expected to be performed within the next 6 months.
  15. Previous heart transplant or heart transplant expected to be performed within the next 6 months.
  16. Presence of any non-cardiac diseases likely to significantly shorten life expectancy to < 1 year.
  17. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception, such as the oral contraceptive pill, an intrauterine device or surgical sterilization (all women of childbearing potential must have a negative pregnancy test before randomization).
  18. Any condition that in the opinion of the investigator would jeopardize the evaluation on efficacy or safety or be associated with poor adherence to the protocol.
  19. Treatment with any investigational agent or device within 4 weeks of randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586442
Other Study ID Numbers  ICMJE WS1911307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michel White, Montreal Heart Institute
Study Sponsor  ICMJE Montreal Heart Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Michel White, MDMontreal Heart Institute
PRS Account Montreal Heart Institute
Verification Date March 2017

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