NCT02344199

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

January 16, 2015

Last Update Submit

May 17, 2016

Conditions

Heart FailureAcute Myocardial InfarctionHypertension

Outcome Measures

Primary Outcomes (1)

  • Levels of Potassium (K)

    6 months

Secondary Outcomes (2)

  • Safety assessed by number of Adverse Events reported

    6 months

  • Potassium Levels (K)

    6 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Heart Failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiology University Clinic

Alexandroupoli, Alexandroupolis, Greece

Location

Gennimatas General State Hospital

Athens, Attica, Greece

Location

2nd Cardiology Department,

University of Athens, Attikon Hospital, Haidari, Athens, 12462, Greece

Location

Related Publications (8)

  • Preiss D, van Veldhuisen DJ, Sattar N, Krum H, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B, Zannad F, McMurray JJ. Eplerenone and new-onset diabetes in patients with mild heart failure: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2012 Aug;14(8):909-15. doi: 10.1093/eurjhf/hfs067. Epub 2012 May 19.

    PMID: 22611047BACKGROUND

  • Ademi Z, Pasupathi K, Krum H, Liew D. Cost effectiveness of eplerenone in patients with chronic heart failure. Am J Cardiovasc Drugs. 2014 Jun;14(3):209-16. doi: 10.1007/s40256-014-0066-3.

    PMID: 24610254BACKGROUND

  • Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2.

    PMID: 24297687BACKGROUND

  • Collier TJ, Pocock SJ, McMurray JJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. The impact of eplerenone at different levels of risk in patients with systolic heart failure and mild symptoms: insight from a novel risk score for prognosis derived from the EMPHASIS-HF trial. Eur Heart J. 2013 Sep;34(36):2823-9. doi: 10.1093/eurheartj/eht247. Epub 2013 Jul 17.

    PMID: 23864130BACKGROUND

  • Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27.

    PMID: 23810881BACKGROUND

  • Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5.

    PMID: 23042980BACKGROUND

  • Rywik TM. [Summary of the article: Zannad F, McMurray JJV, Krum H et al.; for the EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med, 2011; 364: 11-21]. Kardiol Pol. 2011;69(6):631-2. No abstract available. Polish.

    PMID: 21678313BACKGROUND

  • Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.

    PMID: 21073363BACKGROUND

MeSH Terms

Conditions

Heart FailureHypertension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ioannis Parissis, MD

    Cardiology Department, Attikon University Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

GR(3)