Status:
RECRUITING
SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders
Lead Sponsor:
University of Galway
Collaborating Sponsors:
Health Research Board, Ireland
Conditions:
Orthostatic Hypotension
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Adults ≥ 65 years of age
- Documented history of orthostatic hypotension, defined by decrease in systolic blood pressure (SBP) of ≥20 mmHg or a decrease in diastolic blood pressure (DBP) of ≥10 mmHg within three minutes of standing when compared with blood pressure from the supine position, or at head-up tilt testing.
- A documented history of symptoms consistent with orthostatic hypotension including one of the following: light-headedness, dizziness, feeling faint, feeling like they may black out
- Baseline salt intake expected to be in the moderate range (5-10g/day) based on screening questions
- Willingness to supplement sodium intake
- Ability to provide written informed consent
Exclusion
- Severe supine hypertension (Systolic blood pressure≥180mmHg or diastolic blood pressure \>110mmHg) measured as average of three office readings
- A diagnosis of Heart Failure (New York Heart Association (NYHA) Class III or IV symptoms or known left ventricular ejection fraction 30%, if more than one echo eligibility 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-salt diet for evidence based clinical indication
- Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits) in opinion of research team
- Inability to provide informed consent in the opinion of the investigator (for example due to severe cognitive impairment)
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06188663
Start Date
July 9 2024
End Date
September 1 2026
Last Update
July 10 2024
Active Locations (1)
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1
Clinical Research Facility Galway/Galway University Hospital
Galway, Ireland