Atrial Fibrillation Clinical Trial
— AFCARD-IIOfficial title:
Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation
NCT number | NCT02742207 |
Other study ID # | HMO-15-0645 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 11, 2018 |
Est. completion date | December 2020 |
Verified date | August 2019 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal dysfunction | Creatinine Clearance less 25 percent. | Short term - One month | |
Secondary | Mortality | Death | One year |
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