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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04258410
Other study ID # IRB-PENDING-LG
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date September 2022
Est. completion date January 2024

Study information

Verified date October 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Participants receive either oral Quercetin 1000 g/day or placebo for 20 weeks. Quercetin levels, biomarkers, ultrasounds (heart and muscle), functional assessments will be measured on enrollment and after the intervention. The study coordinator will contact participants weekly to monitor safety and ensure compliance. All quercetin administration will be supervised by Claudia L Campos, MD, Associate Professor of Internal Medicine, Medical Director Internal Medicine clinic.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 60 Years to 74 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo oral soft chew
placebo identical to experimental drug contained in soft chew
Quercetin
experimental drug contained in soft chew

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Other Changes in left ventricular systolic function Measure left ventricular ejection fraction (LVEF) by transthoracic echocardiogram (TTE), pre and post intervention Baseline and 20 weeks
Other Changes in left ventricular diastolic function Measures of myocardial relaxation by early septal mitral annular velocity (e') via tissue Doppler, and early-to-late transmitral filling velocity ratios (E/A) via Doppler from transthoracic echocardiogram, pre and post intervention Baseline and 20 weeks
Other Changes in left ventricular filling pressure Calculate ratio of early transmitral filling (E)-to-mitral annular velocity (e'), or E/e', by Doppler-derived images from TTE, pre and post intervention Baseline and 20 weeks
Other Changes in left ventricular (LV) structure Calculate LV mass and relative wall thickness from standard TTE images, pre and post intervention Baseline and 20 weeks
Other Changes in left atrial structure Measure left atrial volume by TTE, pre and post intervention Baseline and 20 weeks
Other Changes in skeletal muscle quality Echo-intensity, in pixels, of the vastus lateralis muscle of the thigh will be measured using ultrasound, pre and post intervention. Baseline and 20 weeks
Other Changes in skeletal muscle composition Measure subcutaneous fat adjacent to vastus lateralis muscle by ultrasound, pre and post intervention Baseline and 20 weeks
Other Changes in exercise capacity 6-minute walk distance (6 MWD), pre and post intervention Baseline and 20 weeks
Other Changes in skeletal muscle strength Five times sit-to-stand test, pre and post intervention Baseline and 20 weeks
Other Changes in biomarker of inflammation Blood sample for measure of high-sensitivity C-reactive protein (hs-CRP), pre and post intervention Baseline and 20 weeks
Other Changes in biomarker of oxidative stress Blood sample for determination of malondialdehyde by ELISA assay, pre and post intervention Baseline and 20 weeks
Other Changes in biomarker of anti-oxidant defense Blood sample for glutathione levels using a commercial assay kit, pre and post intervention Baseline and 20 weeks
Other Changes in biomarker of LV remodeling Blood sample for N terminal-ProBNP levels using the Roche Assay, pre and post intervention Baseline and 20 weeks
Primary Feasibility: Number of enrolled participants per month Proportion of eligible participants enrolled each month, over the course of recruitment. up through 13 months
Primary Eligibility: Proportion eligible after screening Proportion of eligible participants that are invited to participate after initial screening and reasons for declining enrollment. baseline
Secondary Adherence: Percent adherence to study visits Missing data will be quantified, and reasons for failure to follow-up will be determined through informal comments from participants, via phone contact, to assess adherence barriers. 20 weeks
Secondary Adherence: Percent adherence to intervention Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group. 20 weeks
Secondary Retention: Number of Subjects Lost to Follow Up Missing data and drop-out will be quantified, and reasons for lost to follow up will be evaluated through informal comments from participants and Likert-ranked questions to assess participant perceptions of strengths and weaknesses of the study. 20 weeks
Secondary Retention: Number of Subjects Discontinued Participants that are prematurely terminated or discontinued from the study will be quantified. The circumstances that may warrant discontinuation will be evaluated and recorded. 20 weeks
Secondary Acceptability: Changes in patient satisfaction Likert-ranking to assess participant perceptions of the strengths and weaknesses of the study. Scores range from 1 to 5 with a higher score denoting a positive outcome. Baseline and week 20
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