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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
- 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).
- To evaluate the safety of long-term use of trans-resveratrol in an amount of 500 mg per day.
- To develop modern measures to influence the development of CHF in women of this group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点