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NCT06828211

Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD

Sponsor: OMNIFARMA LLC

View on ClinicalTrials.gov

Summary

1. To measure the ability of trans-resveratrol to influence the development of chronic heart failure (CHF) in women in the early postmenopausal period (1-4 years) with hypertension (HTN) and reduced bone mineral density (BMD). 2. To evaluate the safety of long-term use of trans-resveratrol in an amount of 500 mg per day. 3. To develop modern measures to influence the development of CHF in women of this group

Official title: Prospective Open Randomized Controlled Trial on the Effectiveness and Tolerability of Trans-resveratrol (derived from Polygonum Cuspidatum Root Extr.) on the Development of CHF in Postmenopausal Women with HTN and Reduced BMD

Key Details

Gender

FEMALE

Age Range

45 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-09

Completion Date

2025-03-31

Last Updated

2025-03-19

Healthy Volunteers

Conditions

Heart Failure Arterial Hypertension Osteopenia Menopause

Interventions

DIETARY_SUPPLEMENT

Trans-resveratrol extract from Polygonum Cuspidatum

OTHER

Placebo

Inclusion Criteria: * availability of a signed Informed Consent (Information Sheet) of the patient to participate in the clinical trial; * female patients in the postmenopausal period (1-4 years) with hypertension (stage I-II, stage I-II), which is established according to the classification of arterial hypertension (HTN) by stages, degrees and cardiovascular risk. Accordingly, the indicators SBP within 140 - 159 mmHg, DBP 90 - 99 mmHg - HTN stage I; SBP within 160 - 179 mmHg, DBP 100 - 109 mmHg - HTN stage II. Depending on the damage to target organs: Stage I - objective signs of organic damage to target organs are absent; Stage II - there are objective signs of target organ damage without symptoms or dysfunction: LV hypertrophy (according to ECG, Echo-CG, MRI). * reduced bone mineral density (BMD), which meets the criteria for osteopenia of the I-III degree, established by ultrasound densitometry: osteopenia of the I degree T-score from -1.0 to -1.5, II degree T-score from -1.5 to -2.0, III degree T-score from -2.0 to -2.5; * patient's readiness for adequate cooperation in the process of clinical trials. Exclusion Criteria: * diagnosed congenital or acquired heart defects; * established non-coronary myocardial diseases (myocarditis, cardiomyopathy); * rhythm or conduction disorders with concomitant hemodynamic disorders (extrasystoles, paroxysmal tachycardias, atrial fibrillation/flutter, AV block 2 and 3 degrees); * endocrine diseases, blood system diseases, systemic connective tissue diseases; * diagnosed chronic obstructive pulmonary disease; * impaired renal function (glomerular filtration rate according to the CKD-EPI formula less than 60 ml/min), liver. * verified oncological diseases; * abnormal uterine bleeding, endometriosis, pelvic inflammatory diseases; * endometrial polyps and large uterine fibroids; * inflammatory bowel diseases (IBD): Crohn's disease, nonspecific ulcerative colitis; * hormone therapy; * artificial early menopause; * HIV/AIDS; * alcohol or drug addiction; * intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine or blueberries; * participation in other clinical trials

Locations (1)

Omnifarma LLC

Kyiv, Kyiv Oblast, Ukraine