NCT06828211Active, not recruiting
Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 15 Jan 2025
- Start date
- 9 Sept 2024
- Primary completion date
- 9 Feb 2025
- Lead sponsor
- OMNIFARMA LLC
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT06828211
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 9 Sept 2024 to the primary completion date, 9 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- rhythm or conduction disorders with concomitant hemodynamic disorders (extrasystoles, paroxysmal tachycardias, atrial fibrillation/flutter, AV block 2 and 3 degrees);
- hormone therapy;
- alcohol or drug addiction;
Other illness
- diagnosed congenital or acquired heart defects;
- established non-coronary myocardial diseases (myocarditis, cardiomyopathy);
- endocrine diseases, blood system diseases, systemic connective tissue diseases;
- diagnosed chronic obstructive pulmonary disease;
- verified oncological diseases;
- abnormal uterine bleeding, endometriosis, pelvic inflammatory diseases;
- inflammatory bowel diseases (IBD): Crohn's disease, nonspecific ulcerative colitis;
- HIV/AIDS;
- intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine or blueberries;
Other
- impaired renal function (glomerular filtration rate according to the CKD-EPI formula less than 60 ml/min), liver.
- endometrial polyps and large uterine fibroids;
- artificial early menopause;
- participation in other clinical trials
Who the study is looking for
- 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.
Age in the registry: 45 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Omnifarma LLC Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.