Fludrocortisone's Test in Salt Sensitivity
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|ClinicalTrials.gov Identifier: NCT01453959|
Recruitment Status : Unknown
Verified October 2011 by Decio Mion Jr., University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : October 18, 2011
Last Update Posted : October 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Fludrocortisone Other: Diet cycles||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fludrocortisone's Test in the Identification of Salt Sensitivity|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||June 2013|
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
- Blood pressure difference [ Time Frame: Baseline and 11 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453959
|Contact: Andrea P Abreu, MD||(5511) firstname.lastname@example.org|
|General Hospital of School of Medicine - Universiy of Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 05403-000|
|Contact: Andrea P Abreu, MD (5511) 86921219 email@example.com|
|Contact: Decio Mion Junior, MD, PhD (5511) 26617686 firstname.lastname@example.org|
|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|