Cardiovascular DiseaseNCT02088307
Study of the Cardiovascular Vitamin, CardioLife
A study testing CardioLife in people with Cardiovascular Disease, run by University of Utah at 1 site in United States.
Trial summary
Evaluation of the metabolic and physiological characteristics of patients with diagnosed Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- CardioLife
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
About this study
Official title: Evaluation of the Metabolic and Physiological Profiles of Patients Diagnosed With Cardiovascular Disease (CVD) Following Administration of the Novel Cardiovascular Vitamin, CardioLife
Evaluation of the metabolic and physiological characteristics of patients with diagnosed Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- CardioLife
- Keywords
- cardiovascular supplement, cardiovascular disease, coronary artery disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioLifeDietary supplement
Participants randomized to treatment arm will take dietary supplement as instructed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: CardioLife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: Baseline to 6 months
Secondary outcomes (6)
Change in serum lipid levels
Measured: Baseline to 6 Months
Change plasma levels of endothelial progenitor cells (EPC)
Measured: Baseline to 6 Months
Change in cholesterol levels
Measured: 6 months
Change in homocysteine levels
Measured: 6 months
Change in erythrocyte sedimentation rate (ESR) levels
Measured: 6 months
Change in hs-C-reactive protein (CRP) levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar Tandar, University of Utah
- Investigators
- Anwar Tandar, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088307
- Sponsor's protocol ID
- CARDIOLIFE--001
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Metabolic and Physiological Profiles of Patients Diagnosed With Cardiovascular Disease (CVD) Following Administration of the Novel Cardiovascular Vitamin, CardioLife
- ClinicalTrials.gov ID
- NCT02088307
- Acronym / sponsor ID
- CARDIOLIFE--001
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular supplement, cardiovascular disease, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in the control arm will not receive an intervention. |
| CardioLife | Experimental | Dietary Supplement: CardioLifeThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioLifeParticipants randomized to treatment arm will take dietary supplement as instructed. | Dietary supplement | CardioLife |
Primary outcome
Change in blood pressure
Time frame: Baseline to 6 months
6 secondary outcomes
Change in serum lipid levels
Time frame: Baseline to 6 Months
Change plasma levels of endothelial progenitor cells (EPC)
Time frame: Baseline to 6 Months
Change in cholesterol levels
Time frame: 6 months
Change in homocysteine levels
Time frame: 6 months
Change in erythrocyte sedimentation rate (ESR) levels
Time frame: 6 months
Change in hs-C-reactive protein (CRP) levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwar Tandar, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioLife in people with Cardiovascular Disease, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.