An interventional study of Sodium intake reduction and Exercise in Sodium Intake and Resistant Hypertension, sponsored by DongGuk University. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by DongGuk University · Not applicable, Interventional, and Treatment
The aim of this study was to evaluate the therapeutic effect of sodium intake reduction by education in patients with resistant hypertension.
The study was designed to maximize the compliance to antihypertensive agents and use optimal doses of antihypertensive agents including diuretics for 2 months before randomization. Patients will be assigned randomly to receiving (1) education of sodium intake reduction and exercise, or (2) education of exercise alone. Education of sodium intake reduction will be blinded to patients, and education of exercise will be provided to both group to blind the subjects. Daytime ambulatory blood pressure is adopted for diagnosis of resistant hypertension to avoid white-coat effect.
The study consists of 3 phases. The first phase is to exclude pseudo-resistant hypertension by improving compliance to antihypertensive medications. Patients should visit with a prescribed antihypertensive drugs to calculate compliance to medication. If patient has compliance to medication >= 85% [= (the number of pills dispensed - the number of pills counted) / the number of pills expected to have been taken (calculated by multiplying the daily dose by the number of days since the date dispensed)], ambulatory blood pressure will be measured.
If the patient had compliance to medication >= 85%, and daytime ambulatory blood pressure >=135/85 mmHg, he will be entered into first phase of treatment. If patient had compliance to medication \<85%, patients will be asked to enhance medication adherence to 85% or more, and revisit after 1 months.
In the first phase of treatment, dose of current antihypertensive medications (diuretics should be included) will be escalated to optimal doses. Three or more classes of antihypertensive drugs should be prescribed, and educate to keep compliance to medication >=85%. The duration of second phase of treatment is 2 months. After start of first phase, there is a monitoring visit monitoring of adverse drug reaction of diuretics for safety. If there is adverse drug reaction, the dose of suspected drug will be decreased. After 2 months of treatment, if daytime ambulatory blood pressure is >= 135/85 mmHg with compliance to medication >=85%, the patients will be entered into second phase of treatment.
In the second phase of treatment, patients will be randomly assigned to receive either education of exercise or education of exercise and low sodium diet (intensive education with education materials). To the patients assigned to exercise education, detailed training of diet control using educational materials will not be provided. The patients will be blinded to educational group assignments. The duration of second phase of treatment is 1 month. Before start and after completion of second phase of treatment, the amount of sodium intake will be measured by 24-hour urine sodium excretion.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →DongGuk University is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
education of sodium intake reduction and regular exercise
Behavioral: Sodium intake reduction · Behavioral: Exercise
education of regular exercise only
Behavioral: Exercise
Provide materials to reduce sodium intake and educate how to reduce sodium intake effectively
Provides materials on exercise methods to reduce blood pressure and educates how to perform exercise effectively
Difference of change of sitting systolic blood pressure
Comparison of the difference of sitting systolic blood pressure after completion of second phase of treatment (sodium intake reduction phase) from randomization of Second phase of treatment between groups
Time frame: from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)
Effect of optimized antihypertensive treatment
Percent of responders (sitting SBP \< 90 mmHg or difference of sitting SBP \> 10 mmHg from randomization) at the end of first phase treatment
Time frame: At the end of First phase of treatment (for 2 months)
Effect of optimized antihypertensive treatment
Comparison of changes of systolic and diastolic blood pressure lowering at the end of the First phase of treatment from baseline
Time frame: From the start to the end of First phase of treatment (for 2 months)
Effect of sodium intake reduction
Difference of change of sitting diastolic blood pressure between groups (exercise vs exercise + sodium intake reduction) after completion of the Second phase of treatment (sodium intake reduction phase) from randomization of Second phase of treatment
Time frame: from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)
Comparison of Percent of responders at the end of first phase treatment between groups
Comparison of percent responders between groups (sitting SBP \< 90 mmHg or difference of sitting SBP \> 10 mmHg from randomization) at the end of second phase of treatment
Time frame: at the end of second phase of treatment (sodium intake reduction phase, for 1 month)
Difference of renin and aldosterone level between non-resistant hypertension vs resistant hypertension
Comparison of renin and aldosterone level between non-resistant hypertension vs resistant hypertension after optimized antihypertensive treatment
Time frame: after completion of first phase treatment (2 months)
Difference of the effect of sodium intake reduction on renin and aldosterone level between responders vs non-responders to sodium intake reduction
Comparison of renin and aldosterone level between responders vs non-responders to sodium intake reduction
Time frame: after completion of second phase treatment (1 month)
Effect of compliance improvement in BP control
Effect of compliance improvement in BP control
Time frame: Phase of improving drug adherence (1 month)
Plan to share: No — The study data will be shared with investigators who will participate this study as primary investigator or sub-investigator.
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jan 2020, 24 months.
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This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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DongGuk University