Therapeutic Effect of Sodium Intake Reduction in Treatment Resistant Hypertension

NCT03424317 | Terminated

• 1 other identifier: DUMC-C1701
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sodium Intake; Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  from randomization to completion of second phase of treatment (sodium intake reduction phase, for 1 month)

Secondary Outcomes (4)

• Effect of optimized antihypertensive treatment

  At the end of First phase of treatment (for 2 months)

• Effect of optimized antihypertensive treatment

  From the start to the end of First phase of treatment (for 2 months)

• Effect of sodium intake reduction

  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

  at the end of second phase of treatment (sodium intake reduction phase, for 1 month)

Other Outcomes (3)

• Difference of renin and aldosterone level between non-resistant hypertension vs resistant hypertension

  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

  after completion of second phase treatment (1 month)

• Effect of compliance improvement in BP control

  Phase of improving drug adherence (1 month)

Study Arms (2)

Sodium intake reduction and exercise

ACTIVE COMPARATOR

education of sodium intake reduction and regular exercise

Behavioral: Sodium intake reduction; Behavioral: Exercise

Exercise

PLACEBO COMPARATOR

education of regular exercise only

Behavioral: Exercise

Interventions

Sodium intake reduction BEHAVIORAL

Provide materials to reduce sodium intake and educate how to reduce sodium intake effectively

Sodium intake reduction and exercise

Exercise BEHAVIORAL

Provides materials on exercise methods to reduce blood pressure and educates how to perform exercise effectively

Exercise; Sodium intake reduction and exercise

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Heart failure stage 3 or 4
• Severe liver disease
• Pregnancy or women in the fertile age not using efficient contraceptive methods
• Alcoholism
• Renovascular disease

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Moo-Yong Rhee, MD

  Dongguk University Ilsan Hospital/Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Model Details: single blind, randomized

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: February 7, 2018
• Study Start: January 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)