Mechanisms of Refractory Hypertension (High and Low Salt Diet)

NCT02357017 | Withdrawn

• 1 other identifier: B000502641
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to test the hypothesis that persistent fluid retention and high sympathetic output contributes to the development of refractory hypertension (HTN). The investigators will determine, in a cross-over assessment of high and low salt diets, if dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN. Moreover, the investigators will determine if dietary sodium restriction lessens the severity of obstructive sleep apnea (OSA) in patients with refractory HTN.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour ambulatory systolic blood pressure (BP).

  The mean change in blood pressure for each group after receiving 4 weeks of either a low salt diet compared to High dietary salt intake. The low-salt meals will be formulated to provide 50 mmol of sodium per day. Two diets with different caloric amounts (2000 or 2500) will be available. High dietary salt intake, NaCl tablets (6 grams/day) will added to the subject's study diet in order to increase dietary sodium intake to \>250 mmol/day.

  baseline to 4 weeks

Study Arms (2)

Low salt diet

ACTIVE COMPARATOR

The low-salt meals will be formulated to provide 50 mmol of sodium per day. Two diets with different caloric amounts (2000 or 2500) will be available.

Dietary Supplement: NaCl tablets

High salt diet

ACTIVE COMPARATOR

High dietary salt intake, NaCl tablets (6 grams/day) will added to the subject's study diet in order to increase dietary sodium intake to \>250 mmol/day.

Dietary Supplement: NaCl tablets

Interventions

NaCl tablets DIETARY_SUPPLEMENT

High salt diet; Low salt diet

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects ≥ 19 years of age
• Refractory hypertension defined as office BP \> 140/90 that is uncontrolled with at least 5 different classes of antihypertensive medications
• Self-reported adherence \>80% with prescribed antihypertensive medications

You may not qualify if:

• Severe hypertension (office BP \>160/100 mm Hg)
• History of congestive heart failure (ejection fraction of \<40%)
• Chronic kidney disease (creatinine clearance \<60 ml/min)
• History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
• White coat hypertension defined as office BP \>140/90 mm Hg and ambulatory daytime BP \<135/85 mm Hg
• Pregnant or nursing women

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David A. Calhoun, MD

  Cardiology Department - University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06