Clinical trial NCT02088307: Study of the Cardiovascular Vitamin, CardioLife
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: cardiovascular supplement
cardiovascular disease
coronary artery disease
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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.

Eligibility 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

Primary outcomes:
measure: Change in blood pressure
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in serum lipid levels
timeFrame: Baseline to 6 Months
measure: Change plasma levels of endothelial progenitor cells (EPC)
timeFrame: Baseline to 6 Months
measure: Change in cholesterol levels
timeFrame: 6 months
measure: Change in homocysteine levels
timeFrame: 6 months
measure: Change in erythrocyte sedimentation rate (ESR) levels
timeFrame: 6 months
measure: Change in hs-C-reactive protein (CRP) levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
Study officials:
affiliation: University of Utah
name: Anwar Tandar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: