Clinical trial NCT06828211: Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Arterial Hypertension
Osteopenia
Menopause
Lead sponsor: OMNIFARMA LLC
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From enrollment to the end of treatment (3 month for each patient)
measure: The safety of long-term using of trans-resveratrol in the amount of 500 mg per day
timeFrame: From enrollment to the end of treatment (3 month for each patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Omnifarma LLC
Study officials:
References: