Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD (Not aplicable)

OMNIFARMA LLC

Status: Active, not recruiting

Conditions: Osteopenia; Menopause; Arterial Hypertension; Heart Failure

Treatments: Dietary Supplement: Trans-resveratrol extract from Polygonum Cuspidatum; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06828211

Was not given (Other Identifier)

27/08-1/OD/PD

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Trans-resveratrol extract from Polygonum Cuspidatum

Placebo group

Placebo Comparator group

Description:

Placebo group - 30 patients, female postmenopausal (1-4 years) with hypertension (stage I-II) and decreased bone mineral density

Treatment:

Other: Placebo