Trans-resveratrol's Influence on the Development of CHF i... | NCT06828211

ID	Type	Description	Link
Was not given	Other Identifier	Omnifarma LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum	Active Comparator	Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum has been assigned Trans-resveratrol extract from Polygonum Cuspidatum intervention - 50 patients, female postmenopausal (1-4 years) with hypertension (stage I-II) and decreased bone mineral density	Dietary Supplement: Trans-resveratrol extract from Polygonum Cuspidatum
Placebo group	Placebo Comparator	Placebo group - 30 patients, female postmenopausal (1-4 years) with hypertension (stage I-II) and decreased bone mineral density	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trans-resveratrol extract from Polygonum Cuspidatum	Dietary Supplement	Trans-resveratrol extract from Polygonum Cuspidatum	Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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).	From enrollment to the end of treatment (3 month for each patient)
The safety of long-term using of trans-resveratrol in the amount of 500 mg per day	The level of adverse events that does not exceed 5% of the sample size (N=50).	From enrollment to the end of treatment (3 month for each patient)

Eligibility Module

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

ID	Term
D006333	Heart Failure
D006973	Hypertension
D001851	Bone Diseases, Metabolic

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases