SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

Last updated: July 9, 2024
Sponsor: University of Galway
Overall Status: Active - Recruiting

Phase

2

Condition

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Orthostatic Hypotension

Treatment

Salt supplementation (encapsulated sodium chloride)

Clinical Study ID

NCT06188663
C.A.3086
  • Ages > 65
  • All Genders

Study Summary

Background

Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (< 6 weeks).

Clinical Equipoise (Overall)

High salt intake might improve quality of life and reduce the risk of falls, but might also increase the risk of cardiovascular disease, in patients with OH.

Specific Objective of Current Application (Aim)

To determine feasibility (recruitment, retention and adherence) of conducting a randomized controlled trial evaluating high salt intake in older adults with symptomatic orthostatic hypotension.

To determine preliminary estimates of the effect of high salt intake on disease-specific quality of life, orthostatic blood pressure (BP) parameters, and cardiac blood biomarkers.

Design: Phase IIa, parallel, double-blind, randomised controlled, single centre clinical trial of 12 month follow-up duration.

Population: Older adults (≥65 years of age) with an objective diagnosis of symptomatic orthostatic hypotension

Intervention: The intervention will be 5g/day of salt supplementation in the form of encapsulated sodium chloride.

Outcome measures: Primary outcome (Feasibility) recruitment and retention rates, adherence with intervention and study protocol, completeness of follow-up. Secondary Outcome (Efficacy): i) clinical: change in Orthostatic Hypotension Questionnaire score, modification/addition of OH pharmacotherapy, and falls events, ii) physiological measures of orthostasis: change in difference between supine and nadir systolic BP, standing BP at 1 minute, 24 hour mean BP measured by 24 hour ambulatory BP monitor, iii) cardiovascular biomarkers.

Clinical Importance:

A recommendation for long-term increases in salt intake may have adverse cardiovascular consequences, which necessitates the identification of the optimal range of salt intake associated with greatest reduction in falls risk and lowest cardiovascular risk. Our study will provide preliminary evidence of treatment effect and assess feasibility, to inform a definitive trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ≥ 65 years of age

  • Documented history of orthostatic hypotension, defined by decrease in systolic bloodpressure (SBP) of ≥20 mmHg or a decrease in diastolic blood pressure (DBP) of ≥10mmHg within three minutes of standing when compared with blood pressure from thesupine position, or at head-up tilt testing.

  • A documented history of symptoms consistent with orthostatic hypotension includingone of the following: light-headedness, dizziness, feeling faint, feeling like theymay black out

  • Baseline salt intake expected to be in the moderate range (5-10g/day) based onscreening questions

  • Willingness to supplement sodium intake

  • Ability to provide written informed consent

Exclusion

Exclusion Criteria:

  • Severe supine hypertension (Systolic blood pressure≥180mmHg or diastolic bloodpressure >110mmHg) measured as average of three office readings

  • A diagnosis of Heart Failure (New York Heart Association (NYHA) Class III or IVsymptoms or known left ventricular ejection fraction 30%, if more than one echoeligibility is defined by most recent echo)

  • CKD (eGFR <30ml/min/1.73m2) based on eGFR measured within the last 6 months

  • Participants taking loop diuretics

  • Serum sodium <125mmol at last measurement

  • Acute intercurrent illness

  • Prescribed high-salt diet (for clinical indication other than for OH) or low-saltdiet for evidence based clinical indication

  • Participant unlikely to comply with study procedures or follow-up visits due tosevere comorbid illness or other factor (e.g. inability to travel for follow-upvisits) in opinion of research team

  • Inability to provide informed consent in the opinion of the investigator (forexample due to severe cognitive impairment)

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Salt supplementation (encapsulated sodium chloride)
Phase: 2
Study Start date:
July 09, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Clinical Research Facility Galway/Galway University Hospital

    Galway,
    Ireland

    Active - Recruiting

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