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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Menopause; Osteopenia; Arterial Hypertension
• Intervention / Treatment: Other: Placebo; Dietary supplement: Trans-resveratrol extract from Polygonum Cuspidatum

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine, 03057
    • Omnifarma LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum; 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; Trans-resveratrol extract from Polygonum Cuspidatum
Placebo Comparator: Placebo group; Placebo group - 30 patients, female postmenopausal (1-4 years) with hypertension (stage I-II) and decreased bone mineral density	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: OMNIFARMA LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Actual): February 9, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Resveratrol
• Other Study ID Numbers: 27/08-1/OD/PD; Was not given (Other Identifier: Omnifarma LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No