Fludrocortisone's Test in Salt Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Fundação de Amparo à Pesquisa do Estado de São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Decio Mion Jr., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01453959
First received: October 14, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

The main hypothesis of this study is look for a clinical and fast test to identify salt sensitivity by administration of fludrocortisone.


Condition Intervention Phase
Hypertension
Drug: Fludrocortisone
Other: Diet cycles
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fundação de Amparo à Pesquisa do Estado de São Paulo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Diet cycles
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)
Fludrocortisone
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).
Drug: Fludrocortisone
Fludrocortisone in a dose of 0.4 mg/day for 7 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 to 65 years
  • Both sexes and all ethnicities;
  • Body Mass Index (BMI) between 20 and 30 kg/m2;
  • Patients with hypertension with systolic blood pressure ​​(SBP) between 140 and 159 mmHg and diastolic blood pressure (DBP) between 90 mm ​​Hg and 99 mm Hg, without medication or after four weeks of placebo

Exclusion Criteria:

  • Moderate/severe hypertension (BP ≥ 160/100 mm Hg) or secondary cause of hypertension;
  • Use of more than two antihypertensive classes at the time of selection;
  • Presence of diabetes mellitus or other endocrine disorders;
  • Presence of renal impairment (creatinine clearance <60 ml / min, calculated by Cockcroft-Gault formula);
  • Presence of heart failure;
  • Presence of cardiac arrhythmias;
  • History of stroke, coronary heart disease (myocardial infarction, angina) and peripheral vascular insufficiency;
  • Presence of liver failure;
  • Alcoholism;
  • Psychiatric disorders;
  • Use of anovulatory or continuous use of other drugs, such as hormonal or nonhormonal anti-inflammatory drugs that may interfere with blood pressure.
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453959

Contacts
Contact: Andrea P Abreu, MD (5511) 86921219 andreapioabreu@gmail.com

Locations
Brazil
General Hospital of School of Medicine - Universiy of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Andrea P Abreu, MD    (5511) 86921219    andreapioabreu@gmail.com   
Contact: Decio Mion Junior, MD, PhD    (5511) 26617686    deciomion@uol.com.br   
Sub-Investigator: Andrea P Abreu, MD         
Principal Investigator: Decio Mion Junior, MD, PhD         
Sponsors and Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Decio Mion Junior, MD, PhD General Hospital of School of Medicine - Universiy of Sao Paulo
  More Information

No publications provided

Responsible Party: Decio Mion Jr., Clinical Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01453959     History of Changes
Other Study ID Numbers: FAPESP 2010/170726
Study First Received: October 14, 2011
Last Updated: October 20, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Fundação de Amparo à Pesquisa do Estado de São Paulo:
hypertension
salt sensitivity
fludrocortisone

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Fludrocortisone
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014