Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

Study Overview
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Brief Summary
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This single-arm, open-label study will assess the safety and tolerability of one daily tablet of a commercially available cardiovascular health dietary supplement by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Although the cardiovascular health dietary supplement being investigated has been on the market for over 20 years, prospective safety data and blood markers of end organ function have not previously been reported.

Detailed Description
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Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events, including myocardial infarction and stroke, and cardiovascular-related mortality with advancing age. Based on population based studies and clinical trials, both systolic blood pressure (SBP) and diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors for cardiovascular disease. The product being studies is a cardiovascular health dietary supplement that has been commercially available since 1993. It is currently sold to healthcare practitioners as well as directly to consumers. Some healthcare providers use the product as part of a plan to treat high blood pressure in their patients. This is the first study collecting prospective safety data on this product.

Official Title
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Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Cardiovascular health dietary supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg upon screening Exclusion Criteria: Bradycardia Initiation of or changes to blood pressure lowering medications within the last month Initiation of or changes to thyroid medications within the last month Currently taking any of the following orally (or they were taken within the last month): Rauwolfia serpentina, Terminalia arjuna, Tribulus terrestris, Convolvulus pluricaulis, Boerhavia diffusa, Rosa vinca, rose powder, or coral powder Beta blockers Alpha blockers Propranolol Digoxin Levodopa Anti-depressant medications Anti-psychotic medications Sedatives or tranquilizers Present or past history of any of the following: Cardiovascular disease Heart surgery Cardiac arrhythmia Abnormal EKG Abnormal echocardiogram Diabetes Chronic liver, kidney or bowel disease Ulcers Gallbladder disease Depression Alcoholism Obstructive sleep apnea and/or use of a continuous positive airway pressure device Parkinson's disease Pheochromocytoma Cancer within the last 5 years Consuming more than fourteen alcoholic beverages per week Current smoking/tobacco use Current illicit and/or recreational drug use Women who are lactating, pregnant or planning pregnancy within the next six months Known intolerance or allergy to study agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiovascular Health Dietary Supplement<br>The cardiovascular health dietary supplement will be administered at a dosage of 1 caplet po per day for a period of 6 months | Dietary Supplement: Cardiovascular health dietary supplement<br>* Herbal/mineral dietary supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of a cardiovascular health dietary supplement assessed by composite changes in multi-system symptoms, a validated mood/depression questionnaire, electrolytes, and surrogate markers of heart, liver and kidney function | Standardized adverse event monitoring form, Patient Health Questionnaire (PHQ-9), electrolytes (sodium, potassium, calcium, magnesium), b-type natriuretic peptide, aspartate aminotransferase, alanine aminotransferase, and estimated glomerular filtration rate | Baseline, 3 months, 6 months |