Status:
UNKNOWN
Fludrocortisone's Test in Salt Sensitivity
Lead Sponsor:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Hypertension
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
Brief Summary
The main hypothesis of this study is look for a clinical and fast test to identify salt sensitivity by administration of fludrocortisone.
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 individ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01453959
Start Date
July 1 2011
End Date
June 1 2013
Last Update
October 21 2011
Active Locations (1)
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1
General Hospital of School of Medicine - Universiy of Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000