Renal Function Post Cardioversion for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— AFCARD-II  

Official title:

Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02742207
• Other study ID #: HMO-15-0645
• Status: Recruiting
• Start date: July 11, 2018
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with new onset atrial fibrillation

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardioversion
• Renal Insufficiency

Intervention

Other:
• Electrical atrial fibrillation Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation
• Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal dysfunction	Creatinine Clearance less 25 percent.	Short term - One month
Secondary	Mortality	Death	One year