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

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

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Key information

Conditions

Heart Failure Arterial Hypertension Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Heart Diseases Hypertension Menopause Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Vascular Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Omnifarma LLC

Kyiv, Kyiv Oblast, 03057, Ukraine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-resveratrol extract from Polygonum Cuspidatum

Dietary Supplement

Trans-resveratrol extract from Polygonum Cuspidatum

Placebo

Other

Placebo

Primary outcomes

To measure the influence of trans-resveratrol on a development of chronic heart failure in early postmenopausal women period (1-4 years) with arterial hypertension and decreased bone mineral density

Time frame: From enrollment to the end of treatment (3 month for each patient)
- Percentage of patients in whom the use of 500 mg trans-resveratrol daily contributed to the normalization of laboratory and instrumental parameters;
- Percentage of patients in whom the use of 500 mg trans-resveratrol daily contributed to the normalization of quality of life (according to the MENQOL and EuroQol-5D-3L questionnaires);
- Percentage of patients in whom the use of 500 mg trans-resveratrol daily contributed to the reduction of risks of low-trauma fractures (according to the FRAX scale);
- Percentage of patients in whom the use of 500 mg trans-resveratrol daily contributed to the reduction of cardiovascular risk (according to the SCORE2 algorithm and ST2 scale).
The safety of long-term using of trans-resveratrol in the amount of 500 mg per day

Time frame: From enrollment to the end of treatment (3 month for each patient)

The level of adverse events that does not exceed 5% of the sample size (N=50).

Sponsors and collaborators

Lead sponsor

OMNIFARMA LLC

Industry

Registry information

Official study 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

Acronym: Not aplicable

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 14, 2025
Registry last updated: Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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