Sodium IntakeNCT03424317
Therapeutic Effect of Sodium Intake Reduction in Treatment Resistant Hypertension
A study testing Sodium intake reduction and Exercise in people with Sodium Intake and Resistant Hypertension, run by DongGuk University at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sodium Intake, Resistant Hypertension
- What is being tested?
- Sodium intake reduction and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals who agreed to participate in the study and submitted written informed consent
- individuals aged 20 or more years
- Hypertensive patients whose blood pressure is not controlled normally while taking three or more antihypertensive agents including diuretics
- Diuretics should be Hydrochlorothiazide or Indapamide
Who cannot join
- Systolic blood pressure ≥ 220 mmHg
- Chronic kidney disease: estimated Glomerular filtration rate by Modification of Diet in Renal Disease formula ≤ 30 mL/min
- Hyperkalemia (>5.5 mmol/L) or hypokalemia (<3.5 mmol/L)
- Hyponatremia (<135 mmol/L)
- Major cardiovascular events (MI, unstable angina, coronary revascularization, stroke) within 6 month of screening
- Retinal bleeding within 3 months
Show all 11Show fewer
- Heart failure stage 3 or 4
- Severe liver disease
- Pregnancy or women in the fertile age not using efficient contraceptive methods
- Alcoholism
- Renovascular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
About this study
Official title: Evaluation of the Therapeutic Effect of Sodium Intake Reduction by Education in Patients With Treatment Resistant Hypertension
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.
Read the detailed description
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.
- Conditions
- Sodium Intake, Resistant Hypertension
- Being tested
- Sodium intake reduction, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium intake reductionBehavioural
Provide materials to reduce sodium intake and educate how to reduce sodium intake effectively
ExerciseBehavioural
Provides materials on exercise methods to reduce blood pressure and educates how to perform exercise effectively
| Study group | Role | What they receive |
|---|---|---|
| Sodium intake reduction and exercise | Active comparator | education of sodium intake reduction and regular exercise Receives: Behavioral: Sodium intake reduction; Behavioral: Exercise |
| Exercise | Placebo comparator | education of regular exercise only Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: at the end of second phase of treatment (sodium intake reduction phase, for 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Jan 2020
- Study completion31 Aug 2020
Why it stopped: difficult in recruitment, frequent withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind, randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo-Yong Rhee, DongGuk University
- Investigators
- Moo-Yong Rhee, MD, Principal investigator, Dongguk University Ilsan Hospital/Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424317
- Sponsor's protocol ID
- DUMC-C1701
- Status last verified
- Jul 2021
- First submitted
- 16 Nov 2017
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will be shared with investigators who will participate this study as primary investigator or sub-investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effect of Sodium Intake Reduction by Education in Patients With Treatment Resistant Hypertension
- ClinicalTrials.gov ID
- NCT03424317
- Acronym / sponsor ID
- DUMC-C1701
- Conditions
- Sodium Intake, Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult in recruitment, frequent withdrawal
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Sodium intake reduction and exercise | Active comparator | Behavioral: Sodium intake reduction, Behavioral: Exerciseeducation of sodium intake reduction and regular exercise |
| Exercise | Placebo comparator | Behavioral: Exerciseeducation of regular exercise only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals who agreed to participate in the study and submitted written informed consent
- individuals aged 20 or more years
- Hypertensive patients whose blood pressure is not controlled normally while taking three or more antihypertensive agents including diuretics
- Diuretics should be Hydrochlorothiazide or Indapamide
Key exclusion criteria (11 listed)
- Systolic blood pressure ≥ 220 mmHg
- Chronic kidney disease: estimated Glomerular filtration rate by Modification of Diet in Renal Disease formula ≤ 30 mL/min
- Hyperkalemia (>5.5 mmol/L) or hypokalemia (<3.5 mmol/L)
- Hyponatremia (<135 mmol/L)
- Major cardiovascular events (MI, unstable angina, coronary revascularization, stroke) within 6 month of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium intake reductionProvide materials to reduce sodium intake and educate how to reduce sodium intake effectively | Behavioural | Sodium intake reduction and exercise |
| ExerciseProvides materials on exercise methods to reduce blood pressure and educates how to perform exercise effectively | Behavioural | Exercise, Sodium intake reduction and exercise |
Primary outcome
Difference of change of sitting systolic blood pressure
Time frame: from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)
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
4 secondary outcomes
Effect of optimized antihypertensive treatment
Time frame: At the end of First phase of treatment (for 2 months)
Effect of optimized antihypertensive treatment
Time frame: From the start to the end of First phase of treatment (for 2 months)
Effect of sodium intake reduction
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
Time frame: at the end of second phase of treatment (sodium intake reduction phase, for 1 month)
Results and safety
The study was stopped early (reason given: difficult in recruitment, frequent withdrawal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No. The study data will be shared with investigators who will participate this study as primary investigator or sub-investigator.
Related trials for Sodium Intake
RecruitingObservational study
Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
Dietary Sources of Sodium, Population Sodium Intake
RecruitingPhase 4
The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
Atopic Dermatitis (Eczema), Psoriasis
Active, not recruitingPhase 2
SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders
Orthostatic Hypotension
Recruiting
Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults
Healthy Older Adults
Recruiting
Salt Intake and Blood Pressure Control in Adults With Essential Hypertension
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo-Yong Rhee, MD principal investigator
Dongguk University Ilsan Hospital/Cardiovascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium intake reduction and Exercise in people with Sodium Intake and Resistant Hypertension, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficult in recruitment, frequent withdrawal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of change of sitting systolic blood pressure (time frame: from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.