The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk (ARMOPREVCVR)
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Purpose
Cardiovascular risk has been shown to increase with increasing blood pressure values. As a consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive patients, taking into account that all drugs always have some side effects that can be very dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus, pharmacological treatment should be delayed until it results really necessary.
The availability of natural substances with a therapeutic action has modified this scenario because of their reduced potential to cause undesirable effects (compared with drugs). In order to choose among various nutraceuticals (natural foods compounds with health benefits, including the prevention and/or treatment of diseases), preference should be given to those
- produced according to the same Good Manufacturing Practice used for drugs, to be sure that the finished product has a standard, reproducible composition
- for which efficacy and safety in the recommended indications are supported by clinical trials.
An example of a product with these characteristics is Armolipid Plus, a combination of nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical intervention study showed evidence that treatment with Armolipid Plus leads to a significant decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.
Progress in Research and Development in this field has led to a new patented and registered combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.
In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev has a significant antihypertensive effect, which is beneficial in all those patients with high blood pressure values without a defined indication to begin a pharmacological treatment according to the current guidelines. The antihypertensive effect of Armolipid Prev, documented by ambulatory blood pressure monitoring, in addition to the lowering effect on dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and early, effective and safe cardiovascular disease prevention.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: Armolipid Prev |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Study on the Role of a Combination of Nutraceuticals (Armolipid Prev) With an Effect on Blood Pressure and Lipids in the Control of Cardiovascular Risk |
- Cardiovascular risk [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Reduction the global cardiovascular risk calculated according to Framingham risk score compared to baseline.
Reduction of incident metabolic syndrome defined according to ATPIII criteria compared to baseline.
Reduction of the prevalence of microalbuminuria evaluated by standard methods compared to baseline.
Reduction of the prevalence of left ventricular hypertrophy evaluated by the ECG using the current ECG criteria (the Sokolow-Lyon index) compared to baseline.
- Life style [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Increasing compliance with a healthy lifestyle assessed by office interview of the patients at baseline and at the end of follow-up
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: Armolipid Prev
Ortosiphon 300 mg/die, CoQ10 15 mg/die, Berberine 500 mg/die, red yeast 60 mg/die, policosanol 10 mg/die, Folic acid 200 mg/die
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with diagnosis of metabolic syndrome and requiring a blood pressure reduction without any indication to start a pharmacological therapy or in whom stable drug therapy has not achieved the desired results
The presence of at least 3 of the following 5 factors:
- increased blood pressure (≥ 130/85 and ≤ 140/90 mmHg)
- serum triglycerides ³150 mg/dL
- serum HDL cholesterol ≤ 40 mg/dL (males), ≤ 50 mg/dL (females)
- abdominal girth ≥ 104 cm (males), ≥ 88 cm (females)
- elevated fasting blood glucose ≥ 100 mg/dL
Exclusion Criteria:
- Diabetics or hypertensive subjects with an indication to start a pharmacological therapy
- Patients under lipid-lowering treatment
- Pregnant or breast-feeding women according to the Package Leaflet
Patients who require cholesterol-lowering drug therapy in accordance with the international guidelines will not be included in the study population
Contacts and Locations| Contact: Bruno Trimarco, MD | +390817462250 | trimarco@unina.it |
| Contact: Raffaele Izzo, MD | +390817462211 | raffaele.izzo@unina.it |
| Italy | |
| Ambulatorio Ipertensione e Unità Coronarica Federico II University | Recruiting |
| Napoli, Italy, 80131 | |
| Contact: Nicola De Luca, MD +390817462211 nicola.deluca@unina.it | |
| Contact: Raffaele Izzo, MD +390817462211 raffaele.izzo@unina.it | |
| Principal Investigator: Bruno Trimarco, MD | |
| Study Director: | Bruno Trimarco, MD | Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascoalri ed Immunologiche |
More Information
Additional Information:
Publications:
| Responsible Party: | Bruno Trimarco, Full Professor of Cardiology, Federico II University |
| ClinicalTrials.gov Identifier: | NCT01293162 History of Changes |
| Other Study ID Numbers: | ARMOPREV-2011 |
| Study First Received: | February 9, 2011 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Italy: Ethics Committee Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency |
Keywords provided by Federico II University:
|
Metabolic syndrome Cardiovascular risk |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Folic Acid Vitamin B Complex Policosanol Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Platelet Aggregation Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 17, 2013