Renal Function Post Cardioversion for Atrial Fibrillation

NCT ID: NCT02742207

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-12-31

Brief Summary

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Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema.

In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.

Detailed Description

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Conditions

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Atrial Fibrillation Renal Insufficiency Cardioversion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

All comers with Atrial fibrillation

Electrical atrial fibrillation Cardioversion

Intervention Type OTHER

Electrical cardioversion for patients admitted for Atrial Fibrillation

Cardioversion

Intervention Type OTHER

Electrical cardioversion for patients admitted for Atrial Fibrillation

Interventions

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Electrical atrial fibrillation Cardioversion

Electrical cardioversion for patients admitted for Atrial Fibrillation

Intervention Type OTHER

Cardioversion

Electrical cardioversion for patients admitted for Atrial Fibrillation

Intervention Type OTHER

Other Intervention Names

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Cardioversion

Eligibility Criteria

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Inclusion Criteria

* All patients with new onset atrial fibrillation

Exclusion Criteria

* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Dan Gilon

Director, Non-Invasive Cardiology/Echocardiography

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Hadas Lamberg, PhD

Role: primary

0097226777572

Role: backup

References

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Hellman Y, Cohen MJ, Leibowitz D, Loncar S, Gozal D, Haviv YS, Haber G, Afifi M, Rosenheck S, Lotan C, Pollak A, Gilon D. The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Cardiology. 2013;124(3):184-9. doi: 10.1159/000346618. Epub 2013 Mar 9.

Reference Type RESULT
PMID: 23485988 (View on PubMed)

Other Identifiers

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HMO-15-0645

Identifier Type: -

Identifier Source: org_study_id

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