Study of the Cardiovascular Vitamin, CardioLife

NCT02088307 | Completed DMC

• 1 other identifier: CARDIOLIFE--001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Disease

Keywords

cardiovascular supplement; cardiovascular disease; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Baseline to 6 months

Secondary Outcomes (6)

• Change in serum lipid levels

  Baseline to 6 Months

• Change plasma levels of endothelial progenitor cells (EPC)

  Baseline to 6 Months

• Change in cholesterol levels

  6 months

• Change in homocysteine levels

  6 months

• Change in erythrocyte sedimentation rate (ESR) levels

  6 months

Study Arms (2)

Control

NO INTERVENTION

Subjects in the control arm will not receive an intervention.

CardioLife

EXPERIMENTAL

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

Interventions

CardioLife DIETARY_SUPPLEMENT

Participants randomized to treatment arm will take dietary supplement as instructed.

CardioLife

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Anwar Tandar, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical), Division of Cardiology

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 14, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)