SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

Launched by UNIVERSITY OF GALWAY · Dec 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether increasing salt intake can help older adults who experience orthostatic hypotension, a condition where blood pressure drops significantly when standing, leading to symptoms like dizziness and an increased risk of falls. The trial aims to see if taking 5 grams of salt daily, in the form of capsules, can improve participants' quality of life and blood pressure when standing. Researchers will also evaluate how feasible it is to conduct this type of study, looking at how many people sign up, stay in the study, and follow the instructions.

To be eligible, participants must be at least 65 years old and have a diagnosed history of orthostatic hypotension, which means they have experienced a notable drop in blood pressure upon standing. They should also have a moderate salt intake of about 5-10 grams per day. Those interested can expect to take the salt capsules daily for a year and participate in follow-up visits to monitor their health. This trial is important because while increasing salt intake might help reduce falls, it could also pose risks for heart health, so finding the right balance is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)