Fludrocortisone's Test in Salt Sensitivity
Recruitment status was Recruiting
The main hypothesis of this study is look for a clinical and fast test to identify salt sensitivity by administration of fludrocortisone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Fludrocortisone's Test in the Identification of Salt Sensitivity|
- Blood pressure difference [ Time Frame: Baseline and 11 weeks ] [ Designated as safety issue: Yes ]Patient will be analised for salt sensitivity in two phases: during the cycle of diets (low and high salt), lasting two weeks, and during administration of fludrocortisone (0.4 mg/day for 7 days). In the begin and finish of each phase (diets and fludrocortisone), blood pressure will be measure by oscilometric methods in the office and by ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM) out-of-office. The difference of blood pressure between each phase will be used to classify the patient in salt sensitive or salt resistant.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
The patient will be analysed for salt sensitivity by two cycle of diets: low salt diet(40mEq Sodium/day by 7 days) and high salt diet (240mEq Sodium/day by 7 days). After 4 weeks without any intervention, the patient will received fludrocortisone in a dose of 0.4 mg/day for 7 days.
Other: Diet cycles
Two cycle of diets: low salt diet(40mEq Sodium/day by 7 days) and high salt diet (240mEq Sodium/day by 7 days)
The patient will received fludrocortisone in a dose of 0.4 mg/day for 7 days. After 4 weeks without any intervention, the patient will be analysed for salt sensitivity by two cycle of diets: low salt diet(40mEq Sodium/day by 7 days) and high salt diet (240mEq Sodium/day by 7 days).
Fludrocortisone in a dose of 0.4 mg/day for 7 days
The relationship between excessive salt intake and hypertension is well established in the literature. However, the intensity of blood pressure increase in response to such intake varies among individuals. The salt sensitivity is, therefore, measurement of blood pressure response to the variation of salt content in the diet in each individual. The importance of sensitivity to salt has been well demonstrated, with higher mortality in both hypertensive patients and in normotensives subjects. Despite this importance, the methods of assessment salt sensitivity are difficult to be adopted into clinical practice. The test considered the standard for sensitivity to salt is the administration of two cycles of low and high sodium diets, and checked the change in mean arterial pressure between the end of the first and second cycles. Note, therefore, that the supply of diets, as well as patient compliance, are difficult in routine clinical practice. The aim of this study is to compare the administration of fludrocortisone in identifying patients with salt sensitive with the gold standard low and high sodium diets. A experimental cross-over study, with 40 uncomplicated hypertensive patients, will be conducted. Initially, all patients are going to stay in a period of washout of antihypertensive medications with a duration of four weeks, receiving placebo. Following this, they will be submitted for salt sensitivity in two phases: during the cycle of diets, lasting two weeks, and during administration of fludrocortisone in a dose of 0.4 mg/day for 7 days. Between these two phases will be a period of four weeks. The order of the phases will be divided by simple randomization. Moreover, we will evaluate the relationship between blood pressure and 24-hour urinary sodium excretion during cycles of diet low / high sodium. After the study, the test accuracy of fludrocortisone will be analyzed by calculating the sensitivity, specificity and positive predictive value and negative, in addition to the construction of a ROC curve for determining a cutoff point to improve the specificity and sensitivity of the test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453959
|Contact: Andrea P Abreu, MD||(5511) email@example.com|
|General Hospital of School of Medicine - Universiy of Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 05403-000|
|Contact: Andrea P Abreu, MD (5511) 86921219 firstname.lastname@example.org|
|Contact: Decio Mion Junior, MD, PhD (5511) 26617686 email@example.com|
|Sub-Investigator: Andrea P Abreu, MD|
|Principal Investigator: Decio Mion Junior, MD, PhD|
|Principal Investigator:||Decio Mion Junior, MD, PhD||General Hospital of School of Medicine - Universiy of Sao Paulo|