Dataset Information

Oral Fludrocortisone Test for Salt-Sensitive Screening in Hypertensive Patients: A Randomized Crossover Trial.

ABSTRACT: Background:Salt sensitivity is associated with an increased cardiovascular risk, but the gold standard method (diet cycles) requires 24-h urine samples and has poor patient compliance. Objectives:Test the hypothesis that oral fludrocortisone (0.4 mg per day for 7 days) is a good alternative in identifying salt-sensitive patients. Methodology:We conducted a randomized crossover study with 30 hypertensive individuals comprising the following steps: (1) washout; (2) phase A (low- and high-sodium diet cycles); (3) washout 2; (4) phase B (fludrocortisone test). Phase A and B steps were performed in a random way. Consistent with the literature, we found that 53.3% were salt-sensitive according to the reference test. Using the ROC curve, the fludrocortisone test defined salt sensitivity by a median blood pressure increase of ?3 mmHg. A good accuracy of fludrocortisone in detecting salt sensitivity was observed (AUC: 0.732±0.065; p<0.001), with 80% sensitivity and 53% specificity. Conclusion:The fludrocortisone test is a good option for screening salt sensitivity in hypertensive patients. However, the low specificity prevents this test from being an ideal substitute to the labor-intensive diet cycles exam in the definition of salt sensitivity. This clinical trial is registered with NCT01453959.

SUBMITTER: Pio-Abreu A

PROVIDER: S-EPMC6276467 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Oral Fludrocortisone Test for Salt-Sensitive Screening in Hypertensive Patients: A Randomized Crossover Trial.

Pio-Abreu Andrea A de Castro Isac I da Silva Giovanio Vieira GV Ortega Katia Coelho KC Mion Decio D

International journal of hypertension 20181115

<h4>Background</h4>Salt sensitivity is associated with an increased cardiovascular risk, but the gold standard method (diet cycles) requires 24-h urine samples and has poor patient compliance.<h4>Objectives</h4>Test the hypothesis that oral fludrocortisone (0.4 mg per day for 7 days) is a good alternative in identifying salt-sensitive patients.<h4>Methodology</h4>We conducted a randomized crossover study with 30 hypertensive individuals comprising the following steps: (1) washout; (2) phase A (l ...[more]

PMID: 30581606

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Project description:ImportanceTuberculous meningitis is associated with high frequency of cerebral salt wasting. There is a paucity of objective information regarding the best method of treatment of this condition.ObjectiveTo evaluate the efficacy and safety of fludrocortisone in the treatment of cerebral salt wasting in patients with tuberculous meningitis.Design, setting, and participantsThis is a single-center, open-label, randomized clinical trial conducted from October 2015 to April 2017 in India. Patients were randomized in a 1:1 ratio to arms receiving saline only or saline plus fludrocortisone, in addition to a standard treatment of 4 antitubercular drugs, prednisolone, and aspirin. The 2 arms were matched for demographic, clinical, and magnetic resonance imaging findings. The patients were followed up for at least 6 months.InterventionsPatients were randomized to a 0.9% solution of intravenous saline with 5 to 12 g per day of oral salt supplementation, with or without the addition of 0.1 to 0.4 mg of fludrocortisone per day.Main outcomes and measuresThe primary end point was the time needed to correct serum sodium levels; secondary end points were in-hospital deaths, disability at 3 months, disability at 6 months, occurence of stroke, and serious adverse reactions.ResultsNinety-three patients with suspected tuberculous meningitis were recruited; 12 did not meet the inclusion criteria, including 4 with alternate diagnoses. A total of 37 patients with cerebral salt wasting were eligible for the study. One refused to participate, and therefore 36 patients were included, with 18 randomized to each group. The median (range) age was 30 (20-46) years, and 19 were male (52.8%). Those receiving fludrocortisone regained normal serum sodium levels after 4 days, significantly earlier than those receiving saline only (15 days; P = .004). In an intention-to-treat analysis, hospital mortality, disability at 3 months, and disability at 6 months did not differ significantly, but fewer infarcts occurred in the deep border zone in the group receiving fludrocortisone (1 of 18 [6%]) vs those in the control arm (6 of 18 [33%]; P = .04). Fludrocortisone was associated with severe hypokalemia and hypertension in 2 patients each, and pulmonary edema occurred in 1 patient. These adverse reactions necessitated discontinuation of fludrocortisone in 2 patients.Conclusions and relevanceFludrocortisone results in earlier normalization of serum sodium levels, but did not affect outcomes at 6 months. Fludrocortisone had to be withdrawn in 2 patients because of severe adverse effects. This study provides class II evidence on the role of fludrocortisone in treatment of hyponatremia associated with cerebral salt wasting in patients with tuberculous meningitis.Trial registrationClinical Trials Registry of India (ctri.nic.in) Identifier: CTRI/2017/10/010255.

Project description:BackgroundExcessive sodium intake is associated with high blood pressure and an increased risk of cardiovascular disease. However, reducing dietary salt has been challenging due to a lack of awareness and a high threshold in detecting saltiness.ObjectivesThe goal of this study is to evaluate the effectiveness of a combined intervention (intensive dietary education, food reformulation, environmental changes to facilitate salt reduction, and salt meter utilization), in comparison to standard education only, on salt intake and blood pressure.MethodsA cluster randomized-controlled trial was conducted on 219 hypertensive adults aged 18 to 70 years in Uthaithani, Thailand. Participants were randomized 1:1 into the intervention group (n = 111) and the control group (n = 108).ResultsThere were no differences in baseline characteristics between groups. The mean systolic and diastolic blood pressure was 143.6 and 82.1 mmHg and 142.2 and 81.4 mmHg in the intervention group, and the control group, respectively. The median 24-hour urinary sodium excretion was 3565 and 3312 mg/day, in the intervention and the control group, respectively. After 12 weeks, the change in systolic blood pressure was -13.5 versus -9.5 mmHg (P = 0.030) and diastolic blood pressure was -6.4 versus -4.8 mmHg (P = 0.164) in the intervention and control groups, respectively. Moreover, a reduction in 24-hour urine sodium excretion was observed [-575 versus -299 mg/day in the intervention and control groups, respectively (P = 0.194)]. The change in 24-hour urine sodium excretion was statistically significant and reduced from baseline in the intervention group (P = 0.004). The dietary salt intake was significantly improved and was statistically different between groups (P = 0.035).ConclusionsThe combined intervention significantly decreased systolic blood pressure and showed a trend towards reduced urine sodium excretion in hypertensive patients. These comprehensive approaches may be beneficial in reducing blood pressure and salt intake in the community.Clinical trial registrationThis trial was registered at Clinicaltrials.gov with the identifier NCT05397054. https://classic.clinicaltrials.gov/ct2/show/NCT05397054.

Project description:Hypertensive cerebropathy is a pathological condition associated with cerebral edema and disruption of the blood-brain barrier. However, the molecular pathways leading to this condition remains obscure. We hypothesize that MMP-9 inhibition can help reducing blood pressure and endothelial disruption associated with hypertensive cerebropathy. Dahl salt-sensitive (Dahl/SS) and Lewis rats were fed with high-salt diet for 6 weeks and then treated without and with GM6001 (MMP inhibitor). Treatment of GM6001 (1.2 mg/kg body weight) was administered through intraperitoneal injections on alternate days for 4 weeks. GM6001 non-administered groups were given vehicle (0.9% NaCl in water) treatment as control. Blood pressure was measured by tail-cuff method. The brain tissues were analyzed for oxidative/nitrosative stress, vascular MMP-9 expression, and tight junction proteins (TJPs). GM6001 treatment significantly reduced mean blood pressure in Dahl/SS rats which was significantly higher in vehicle-treated Dahl/SS rats. MMP-9 expression and activity was also considerably reduced in GM6001-treated Dahl/SS rats, which was otherwise notably increased in vehicle-treated Dahl/SS rats. Similarly MMP-9 expression in cerebral vessels of GM6001-treated Dahl/SS rats was also alleviated, as devised by immunohistochemistry analysis. Oxidative/nitrosative stress was significantly higher in vehicle-treated Dahl/SS rats as determined by biochemical estimations of malondialdehyde, nitrite, reactive oxygen species, and glutathione levels. RT-PCR and immunohistochemistry analysis further confirmed considerable alterations of TJPs in hypertensive rats. Interestingly, GM6001 treatment significantly ameliorated oxidative/nitrosative stress and TJPs, which suggest restoration of vascular integrity in Dahl/SS rats. These findings determined that pharmacological inhibition of MMP-9 in hypertensive Dahl-SS rats attenuate high blood pressure and hypertension-associated cerebrovascular pathology.

Dataset Information

Oral Fludrocortisone Test for Salt-Sensitive Screening in Hypertensive Patients: A Randomized Crossover Trial.

Publications

Oral Fludrocortisone Test for Salt-Sensitive Screening in Hypertensive Patients: A Randomized Crossover Trial.

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