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Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and Persistent Atrial Fibrillation in Preventing Recurrent Episodes of Atrial Fibrillation

NCT02764619 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2016-05-17

No results posted yet for this study

Summary

A randomized, double-blinded, placebo-controlled study to evaluate the effect of spironolactone in addition to conventional treatment compared with placebo in patients with paroxysmal and persistent atrial fibrillation with preserved left ventricular ejection fraction by T1 mapping, structure and function of left atrium and ventricle assessed by transthoracic echocardiography and cardiac magnetic resonance (CMR), the number of recurrent episodes of atrial fibrillation and biomarkers measured in blood.

Conditions

Interventions

DRUG

Spironolactone

DRUG

Placebo

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Takeda

    collaborator INDUSTRY

  • Svendborg Hospital

    lead OTHER

Principal Investigators

  • Kenneth Egstrup, Professor · Department of Cardiovascular Research, Medical Department, Odense University Hospital, Svendborg

  • Dragana Rujic, MD, Ph.D.sc. · Department of Cardiovascular Research, Medical Department, Odense University Hospital, Svendborg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764619 on ClinicalTrials.gov