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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Montreal Heart Institute
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Michel White, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01586442
First received: April 24, 2012
Last updated: May 13, 2014
Last verified: May 2014

April 24, 2012
May 13, 2014
March 2012
December 2014   (final data collection date for primary outcome measure)
  • Glycated hemoglobin [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in glycated hemoglobin
  • Fasting glucose and lipid profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Plasma insulin [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Cortisol [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • NT-proBNP [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • PIIINP [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01586442 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Effects of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Type 2 Diabetes
  • Glucose Intolerance
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
July 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Canada
 
NCT01586442
WS1911307
Yes
Michel White, Montreal Heart Institute
Montreal Heart Institute
Pfizer
Principal Investigator: Michel White, MD Montreal Heart Institute
Montreal Heart Institute
May 2014

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