Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES (NCT05408559) | Clinical Trial Compass
WithdrawnPhase 1/2
Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES
Stopped: Had issue enrolling subjects.
United States0Started 2022-07-01
Plain-language summary
Our local IRB approved clinical studies seeking proof of principle for the hypothesis that SFN can be safely administered to humans at doses sufficient to protect age-associated cardiac dysfunctions. Beneficial effects of SFN-therapy will be assessed by Pre- and post-intervention echocardiography, and exercise endurance at 0 and 24 weeks. Peripheral blood cells from treated and control subjects will be compared for mitochondrial respiratory function, oxidative damage, pro-inflammatory cytokines, and expression of antioxidant \& anti-electrophile genes.
Who can participate
Age range
60 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:
* Age \> 60 years
* Diagnosis of HFpEF (HF symptoms with a normal EF (\>/=50 %)
* Ability to walk more than 500 feet (by self-report)
* Willing to avoid taking all over the counter antioxidant phytochemical supplements (vegetable or fruit-containing supplement pills) during the study
Exclusion Criteria:
* Inability to provide informed consent
* Diagnosis of active cancer
* Inability to read and understand the SF-36 in English
* Participants using over the counter antioxidant supplements
* Participants with pulmonary or other issues which restrict walking capacity
* On oxygen therapy
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
cardiac function
Timeframe: 0 week
2
cardiac function
Timeframe: 24 week
3
Functional Capacity
Timeframe: 0 week
4
Functional Capacity
Timeframe: 24 week
Trial details
NCT IDNCT05408559
SponsorTexas Tech University Health Sciences Center