Arterial Hypertension, Heart Failure, Menopause, Osteopenia
Conditions
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
Interventions
DIETARY_SUPPLEMENTTrans-resveratrol extract from Polygonum Cuspidatum
Trans-resveratrol extract from Polygonum Cuspidatum
OTHERPlacebo
Placebo
Sponsors
OMNIFARMA LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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). |
Countries
Ukraine
Outcome results
None listed