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Trial record 61 of 112 for:    EPLERENONE

Eplerenone in Heart Failure Treatment (INOSET)

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.
 
ClinicalTrials.gov Identifier: NCT02344199
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:

Beta-blockers should be administered to all patients with heart failure stage II to IV according to NYHA.Beta-blockers reduce mortality and hospitalizations and improve the operational phase for all categories of patients with heart failure. Since beta-blockers, only carvedilol, metoprolol, bisoprolol and recently nevimpololi have shown these benefits and so, only they have evidence to be provided.

Eplerenone is indicated, in addition to conventional therapy, for reducing the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤ 40%) and clinically proven heart failure after recent myocardial infarction.


Condition or disease
Heart Failure Acute Myocardial Infarction Hypertension

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 450 participants
Time Perspective: Prospective
Official Title: A Non-interventional, Multicenter, Observational Clinical Trial to Assess Eplerenone Treatment in Patients With Heart Failure.
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone




Primary Outcome Measures :
  1. Levels of Potassium (K) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety assessed by number of Adverse Events reported [ Time Frame: 6 months ]
  2. Potassium Levels (K) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Heart Failure
Criteria

Inclusion Criteria:

  • Eligible ages for the study:> 18 years
  • Patients who are to receive eprelenone according to standard clinical practice
  • Patients with heart failure of ischemic / non-ischemic etiology
  • Patients receiving standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity
  • Stable patients
  • Patients with left ventricular dysfunction (LVEF ≤ 40%)
  • Patients with clinically proven heart failure after recent myocardial infarction.
  • Patients who have fully understood the study protocol and signed the consent form

Exclusion Criteria:

  • Patients <18 years
  • Hypersensitivity to eplerenone in any of the excipients
  • Patients with a serum potassium level> 5,0 mmol / L at the start of therapy
  • Patients with moderate to severe renal impairment (creatinine clearance <50 mL / min)
  • Patients with severe hepatic impairment (Child-Pugh class C)
  • Patients taking diuretics guard potassium loss or strong inhibitors of CYP3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
  • Patients who have not fully understood the study protocol and have not signed the consent form

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 ClinicalTrials.gov identifier (NCT number): NCT02344199


Locations
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Greece
Gennimatas General State Hospital
Athens, Attica, Greece
2nd Cardiology Department,
University of Athens, Attikon Hospital, Haidari, Athens, Greece, 12462
Cardiology University Clinic
Alexandroupolis, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
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Principal Investigator: Ioannis Parissis, MD Cardiology Department, Attikon University Hospital of Athens

Publications:

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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT02344199     History of Changes
Other Study ID Numbers: 2015-PLR-EL-55
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Eplerenone
Heart Failure
Myocardial Infarction
Infarction
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents