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Study of the Cardiovascular Vitamin, CardioLife

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ClinicalTrials.gov Identifier: NCT02088307
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Anwar Tandar, University of Utah

Brief Summary:
Evaluation of the metabolic and physiological characteristics of patients with diagnosed Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: CardioLife Not Applicable

Detailed Description:
The goal of this study is to evaluate the safety and efficacy of cardiovascular nutraceutical supplement, CardioLife™ in patients with diagnosed Cardiovascular Disease (CVD). CardioLife is a novel nutraceutical intended for the prevention and management of cardiovascular risk factors, enhancement of cardiac performance and the treatment of cardiac dysfunction. This is an oral vitamin supplement comprising of the following main ingredients: garlic co-enzyme Q10, Arjuna, Hawthorn, Guggul, Red Yeast Rice, Policosanol, Nattokinase, Tumeric/curcumin, ashangandha, L-carnitine, grape seed extract, and vitamin B12.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Metabolic and Physiological Profiles of Patients Diagnosed With Cardiovascular Disease (CVD) Following Administration of the Novel Cardiovascular Vitamin, CardioLife
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
No Intervention: Control
Subjects in the control arm will not receive an intervention.
Experimental: CardioLife
The main ingredients in the CardioLife supplements are as follows: garlic, co-enzyme Q10, arjuna, hawthorn, guggul, red yeast rice, policosanol, nattokinase, tumeric/curcumin, ashwangandha, L-carnitine, grape seed extract and vitamin B12.
Dietary Supplement: CardioLife
Participants randomized to treatment arm will take dietary supplement as instructed.




Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Change in serum lipid levels [ Time Frame: Baseline to 6 Months ]
  2. Change plasma levels of endothelial progenitor cells (EPC) [ Time Frame: Baseline to 6 Months ]
  3. Change in cholesterol levels [ Time Frame: 6 months ]
  4. Change in homocysteine levels [ Time Frame: 6 months ]
  5. Change in erythrocyte sedimentation rate (ESR) levels [ Time Frame: 6 months ]
  6. Change in hs-C-reactive protein (CRP) levels [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 90 years old and ability to understand the planned study.
  • Patients with Cardiovascular Disease
  • Able to comply with all study-related visits
  • Able to give Informed Consent
  • Negative for HcG with a serum pregnancy test
  • If the patient has diabetes mellitus it must be controlled (HbA1c < 9.0%)
  • Life expectancy of 1 year or more in the opinion of the investigator.
  • Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Serum bilirubin, ALT, AST x 2.5 time the upper level of normal.
  • Controlled blood pressure (systolic blood pressure ≤160 and a diastolic blood pressure of ≤100 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
  • Patient must be on at least three of the listed medications for at least 30 days with no new medications to treat the disease introduced in the last month. Medications are: Anti-Platelet Therapy, Beta-Blockers, ACE/ARB, Calcium Blocker, Nitrates, After Load Reducing Agents, Lipid Lowering Agents, and/or Diuretics. Cardiac medications must be at stable doses with no dose change within the last 30 days.

Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia are adequately controlled in the opinion of the investigator)

  • Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.

Exclusion Criteria:

  • Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
  • End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
  • Acute Myocardial Infarction 90 days prior to randomization.
  • Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
  • Life expectancy <1 year due to concomitant illnesses
  • Known cancer or malignancy within the last 5 years
  • Prior admission for substance abuse
  • Uncontrolled lipid levels as determined by the Investigator
  • Untreated Hypothyroidism
  • Known Congenital Heart Defects
  • History of Ischemic and Non-Ischemic Cardiomyopathy or Heart Failure
  • Body Mass Index (BMI) of 45 kg/m2 or greater
  • Medication use of steroids 30 days prior to enrollment
  • Current use of any Nutraceutical that contains ingredients known to affect blood pressure, or any active ingredients that are found in CardioLifeTM
  • Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
  • In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088307


Locations
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United States, Utah
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Anwar Tandar, M.D. University of Utah

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Responsible Party: Anwar Tandar, Assistant Professor (Clinical), Division of Cardiology, University of Utah
ClinicalTrials.gov Identifier: NCT02088307     History of Changes
Other Study ID Numbers: CARDIOLIFE--001
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Keywords provided by Anwar Tandar, University of Utah:
cardiovascular supplement
cardiovascular disease
coronary artery disease

Additional relevant MeSH terms:
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Cardiovascular Diseases
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs