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Trial record 33 of 112 for:    EPLERENONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01586442
Recruitment Status : Unknown
Verified March 2017 by Michel White, Montreal Heart Institute.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Michel White, Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Heart Failure Type 2 Diabetes Glucose Intolerance Drug: Eplerenone Drug: Spironolactone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Spironolactone
spironolactone 12.5mg once daily titrated to 25mg once daily
Drug: Spironolactone
Spironolactone 12,5mg daily titrated to 25mg once daily for 16 weeks
Other Name: Aldactone

Experimental: Eplerenone
Eplerenone 25mg once daily titrated to 50mg once daily
Drug: Eplerenone
Eplerenone 25mg once daily titrated to 50 mg once daily for 4 months
Other Name: Inspra

Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 4 months ]
    Change in glycated hemoglobin

  2. Fasting glucose and lipid profile [ Time Frame: 4 months ]
  3. Plasma insulin [ Time Frame: 4 months ]
  4. Cortisol [ Time Frame: 4 months ]
  5. Adiponectin [ Time Frame: 4 months ]
  6. NT-proBNP [ Time Frame: 4 months ]
  7. PIIINP [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01586442

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
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Principal Investigator: Michel White, MD Montreal Heart Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michel White, Michel White, MD, FRCP(C), FACC, FESC, Montreal Heart Institute Identifier: NCT01586442     History of Changes
Other Study ID Numbers: WS1911307
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents