Heart FailureNot aplicableNCT06828211
Trans-resveratrol's Influence on the Development of CHF in Early Postmenopausal Women with HTN and Reduced BMD
A study testing Trans-resveratrol extract from Polygonum Cuspidatum in people with Heart Failure and Arterial Hypertension, run by OMNIFARMA LLC at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Heart Failure, Arterial Hypertension, Osteopenia
- What is being tested?
- Trans-resveratrol extract from Polygonum Cuspidatum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUkraine
- Study dates
- 9 Sep 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- 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
- Conditions
- Heart Failure, Arterial Hypertension, Osteopenia, Menopause
- Being tested
- Trans-resveratrol extract from Polygonum Cuspidatum, Placebo
- Medical subject headings
- Heart Failure, Hypertension, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-resveratrol extract from Polygonum CuspidatumDietary supplement
Trans-resveratrol extract from Polygonum Cuspidatum
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment to the end of treatment (3 month for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start9 Sep 2024
- Primary completion9 Feb 2025
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OMNIFARMA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828211
- Sponsor's protocol ID
- 27/08-1/OD/PD
- Other IDs
- Was not given
- Acronym
- Not aplicable
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06828211
- Acronym / sponsor ID
- Not aplicable / 27/08-1/OD/PD
- Conditions
- Heart Failure, Arterial Hypertension, Osteopenia, Menopause
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OMNIFARMA LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 9 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum | Active comparator | Dietary Supplement: Trans-resveratrol extract from Polygonum CuspidatumStudy 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 |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo group - 30 patients, female postmenopausal (1-4 years) with hypertension (stage I-II) and decreased bone mineral density |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-resveratrol extract from Polygonum CuspidatumTrans-resveratrol extract from Polygonum Cuspidatum | Dietary supplement | Study group recieving the intervention as Trans-resveratrol extract from Polygonum Cuspidatum |
| PlaceboPlacebo | Other | Placebo group |
Primary outcome
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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-resveratrol extract from Polygonum Cuspidatum in people with Heart Failure and Arterial Hypertension, run by OMNIFARMA LLC at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From enrollment to the end of treatment (3 month for each patient)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.