NCT01453959

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

October 14, 2011

Last Update Submit

October 20, 2011

Conditions

Hypertension

Keywords

hypertensionsalt sensitivityfludrocortisone

Outcome Measures

Primary Outcomes (1)

  • Blood pressure difference

    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.

    Baseline and 11 weeks

Study Arms (2)

Diet cycles

OTHER

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

Fludrocortisone

OTHER

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

Interventions

FludrocortisoneDRUG

Fludrocortisone in a dose of 0.4 mg/day for 7 days

Fludrocortisone
Diet cyclesOTHER

Two cycle of diets: low salt diet(40mEq Sodium/day by 7 days) and high salt diet (240mEq Sodium/day by 7 days)

Diet cycles

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of School of Medicine - Universiy of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

  • Pio-Abreu A, de Castro I, da Silva GV, Ortega KC, Mion D Jr. Oral Fludrocortisone Test for Salt-Sensitive Screening in Hypertensive Patients: A Randomized Crossover Trial. Int J Hypertens. 2018 Nov 15;2018:7437858. doi: 10.1155/2018/7437858. eCollection 2018.

    PMID: 30581606DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Fludrocortisone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Decio Mion Junior, MD, PhD

    General Hospital of School of Medicine - Universiy of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea P Abreu, MD

CONTACT

(5511) 86921219andreapioabreu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

June 1, 2013

Last Updated

October 21, 2011

Record last verified: 2011-10

Locations

BR(1)