The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk (ARMOPREVCVR)
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.
|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
|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)|
|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
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|Contact: Bruno Trimarco, MDfirstname.lastname@example.org|
|Contact: Raffaele Izzo, MDemail@example.com|
|Ambulatorio Ipertensione e Unità Coronarica Federico II University||Recruiting|
|Napoli, Italy, 80131|
|Contact: Nicola De Luca, MD +390817462211 firstname.lastname@example.org|
|Contact: Raffaele Izzo, MD +390817462211 email@example.com|
|Principal Investigator: Bruno Trimarco, MD|
|Study Director:||Bruno Trimarco, MD||Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascoalri ed Immunologiche|