WithdrawnPhase 4

Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

Stopped: Per PI: "Never went to IRB Never recruited anyone Never resubmitted the score NIH application I am leaving the institution"

0Started 2022-09

Plain-language summary

Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women. The study team will conduct a feasibility pilot in preparation for a larger efficacy trial that will test the protective effects of quercetin against cardiac and skeletal muscle dysfunction and changes in structure induced by estrogen loss and potential mechanistic pathways in post-menopausal women at risk of heart failure with preserved ejection fraction (HFPEF).

Who can participate

Age range

60 Years – 74 Years

Sex

FEMALE

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: * Female, postmenopausal, aged 60 to 74 * Stated willingness to comply with all study procedures and availability for the duration of the study * High risk of Heart failure with preserved ejection fraction (HFPEF) using web-based Primary Care Physician-HF risk tool (Khan S, et al.10-Year Risk Equations for Incident Heart Failure in the General Population. Information used for calculation include: age, gender, race, hypertension treatment (yes or no), fasting glucose value, smoking status, body mass index, systolic BP, diabetes treatment (yes or no), total cholesterol, HDL cholesterol, and electrocardiogram QRS duration. Prospective participant's with scores \>= 10% will be included. * Electrocardiogram (EKG) on medical record Exclusion Criteria: * History of congestive heart failure or use of loop diuretics * Recent myocardial infarction (MI), stroke, angina, or atrial fibrillation (in the past 6 months), either self-reported and or in the electronic medical record. * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Significant renal insufficiency requiring dialysis or estimated glomerular filtration rate (eGFR) \< 15 mL/min * Liver disease * Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder * Participants reporting extreme energy intakes \>3500 or \<500 kcal/day * Plans to leave area within the study period * Refuses informed consent

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

Feasibility: Number of enrolled participants per month

Timeframe: up through 13 months

Eligibility: Proportion eligible after screening

Timeframe: baseline

Trial details

NCT IDNCT04258410

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

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