Heat, Microvascular Function and Aging (NCT06633198) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Heat, Microvascular Function and Aging
United States20 participantsStarted 2025-05-01
Plain-language summary
Vascular dysfunction is a common factor in many chronic debilitating diseases, contributing to morbidity and mortality. With the onset of chronic disease or exposure to stress, the vasculature displays an inability to adequately respond to increased blood flow demands, manifesting in a reduced ability or altered mechanism of vasodilation. Aging is an independent risk factor in the development of cardiovascular disease, and reduces vasodilator capacity, or alters the mechanism by which vasodilation occurs in multiple vascular beds. Chronic exercise/physical activity is one of the most potent ways to enhance vascular function, resulting in favorable outcomes such as reductions in blood pressure, and improved ability to perform activities of daily living. Barriers to exercise or failure of long-term adherence preclude many populations from the cardiovascular benefits of exercise, thus further enhancing cardiovascular risk. Avenues to mimic blood flow patterns observed with exercise may exert beneficial effects without the need for the ability to exercise. Recent evidence has demonstrated that passive heat therapy, or chronic heat exposure (\~ +1°C in core temperature) results in reductions in major adverse cardiovascular events, blood pressure and improved large artery endothelial function, primarily through preservation of large artery function in response to vascular stress. It is unclear whether microvascular function is augmented in response to acute heat exposure, or whether this can protect against vascular insults particularly in older adults. Some preliminary evidence in humans suggest that autophagy, a cell recycling process is involved in the beneficial cardiovascular effects, as short-term heat exposure upregulates markers of autophagy. Previous evidence from our lab indicates that autophagy governs the mechanism by which microvascular vasodilation occurs. The role of autophagy in mediating the beneficial effects of passive heating is unknown.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be between 18-80 yrs. of age
* No more than 1 cardiovascular risk factor (see list in exclusion criteria)
Exclusion Criteria:
* Cardiovascular Risk Factors
* Uncontrolled/unmanaged hypertension and/or use of current anti-hypertensive therapy
* Current Tobacco product use or within last 6 months
* BMI greater than 30
* Hyperlipidemia - diagnosed and/or taking medications to manage
* Hypercholesterolemia - diagnosed and/or taking medications to manage (e.g. statins)
* Type 1 or Type 2 Diabetes
* Use of anti-coagulant or anti-platelet drugs
* Use of beta blockers
* Symptomatic coronary artery disease
* Diagnosed Heart Failure (Any classification above Class I as defined by NY Heart Association)
* Diagnosed renal impairment Renal impairment defined, according to National Kidney Foundation as abnormalities of kidney structure or function, present for greater than 3 months, including:
* Albuminuria (ACR ≥ 30 mg/g)
* Urine sediment abnormalities
* Electrolyte and other abnormalities due to tubular disorders
* Structural abnormalities detected by imaging
* History of kidney transplantation
* Decreased glomerular filtration rate (GFP \< 60 mL/min/1.73 m2)
* Current Hormone Replacement Therapy Use
* History of retinopathy
* Documented neuromuscular disorders
* Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
* Pregnancy (Young Female subjects)
* Allergies to povidone iodine
* Tattoos on lower arm (forearm)
* Use of erec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cutaneous microvascular function
Timeframe: Baseline, 60 minutes post I/R, and 60 minutes post hot water immersion + I/R injury