Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD

NCT06828211 | Active Not Recruiting

• 2 other identifiers: 27/08-1/OD/PDWas not given
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the safety of long-term use of trans-resveratrol in an amount of 500 mg per day.
3. 3.To develop modern measures to influence the development of CHF in women of this group

Conditions

Heart Failure; Arterial Hypertension; Osteopenia; Menopause

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

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

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

Placebo OTHER

Placebo

Placebo group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• OMNIFARMA LLC: lead

Study Sites (1)

Omnifarma LLC

Kyiv, Kyiv Oblast, 03057, Ukraine

Location

MeSH Terms

Conditions

Heart Failure; Hypertension; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 14, 2025
• Study Start: September 9, 2024
• Primary Completion: February 9, 2025
• Study Completion: March 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-12

Locations

UA (1)