The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk (ARMOPREVCVR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Federico II University
Sponsor:
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University
ClinicalTrials.gov Identifier:
NCT01293162
First received: February 9, 2011
Last updated: July 10, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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: January 2014
Estimated Primary Completion Date: December 2013 (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:
  • orthosiphon
  • CoQ10
  • berberine
  • red yeast
  • policosanol
  • folic acid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293162

Contacts
Contact: Bruno Trimarco, MD +390817462250 trimarco@unina.it
Contact: Raffaele Izzo, MD +390817462211 raffaele.izzo@unina.it

Locations
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         
Sponsors and Collaborators
Federico II University
Investigators
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 10, 2013
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 July 23, 2014