What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease include statins, antiplatelet agents, and antihypertensive medications. Statins, such as rosuvastatin and atorvastatin, are known to cause side effects like myalgia, increased liver enzymes, and, rarely, rhabdomyolysis. Antiplatelet agents, like aspirin, can increase the risk of bleeding and gastrointestinal ulcers. Antihypertensive medications, including ACE inhibitors and beta-blockers, may cause side effects such as cough, dizziness, and fatigue. These treatments are essential in managing CVD but require monitoring for potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cardiovascular disease. Notably, nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib, naproxen, and ibuprofen have been studied for their cardiovascular safety. However, some, like rofecoxib, were withdrawn due to increased risk of myocardial infarction. Hormone therapy, particularly involving conjugated equine estrogen, has been evaluated for its impact on cardiovascular health, showing mixed results. Additionally, obesity drugs like sibutramine were removed from the market due to cardiovascular risks. These treatments highlight the ongoing efforts to balance efficacy and safety in managing cardiovascular disease.

What other types of research exist?

Promising novel alternatives for addressing the impact of early life stressors on cardiovascular health in 2024 include lifestyle modifications (stress management, regular exercise, healthy diet), pharmacological interventions, psychological support, and emerging therapies focusing on nitric oxide bioavailability.

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Dietary Supplement

Antioxidants + Nitroglycerin for Cardiovascular Health (NO-Stress Trial)

N/A

Waitlist Available

Led By Ryan Harris, PhD

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be lean, overweight, or obese with a BMI less than or equal to 39 kg/m2

Men and premenopausal women ages 18-40

Must not have

Patients with cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic disease

Patients with class 3 obesity or a BMI over 40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (2 hours)

Summary

This trial will test if taking vitamins and antioxidants can improve heart health in people who had stressful childhoods, especially those from low-income backgrounds. The study will compare the effects of the antioxidant mix to a non-active substance.

Who is the study for?

The NO-Stress trial is for men and premenopausal women aged 18-40, who are lean, overweight, or obese with a BMI of 39 or less. Participants must have records of their socioeconomic status during childhood. Those with cardiovascular and other major diseases, postmenopausal women, individuals with class 3 obesity (BMI over 40), or those on meds affecting blood vessel tone cannot join.

What is being tested?

This study tests the effects of an antioxidant cocktail and a nitroglycerin spray under the tongue against a placebo in understanding how early life stress impacts heart health. It also involves taking small tissue samples to study changes at the cellular level.

What are the potential side effects?

Possible side effects may include headaches from nitroglycerin use; discomfort or bruising at biopsy site; allergic reactions to antioxidants; dizziness or low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 39 or less.

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I am a man or a premenopausal woman aged between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart, kidney, lung, liver, brain, or metabolic condition.

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My BMI is over 40, classifying me as having class 3 obesity.

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I am a woman who has gone through menopause.

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I am taking medication that affects blood vessel behavior.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (2 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (2 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (2 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Change in Flow mediated dilation

Secondary study objectives

Acute Change in Arterial Stiffness

Acute Change in Biomarkers of oxidative stress

Acute change in Flow mediated dilation

Trial Design

2Treatment groups

Experimental Treatment

Group I: BiopsyExperimental Treatment1 Intervention

Following an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (\~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography.

Group II: Antioxidant CocktailExperimental Treatment3 Interventions

Following an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antioxidant cocktail

2009

Completed Early Phase 1

~70

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiovascular disease (CVD) include antihypertensives, statins, and antithrombotic agents. Antihypertensives, such as ACE inhibitors and beta-blockers, work by lowering blood pressure, reducing the strain on the heart and blood vessels. Statins help lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol synthesis in the liver, thereby reducing plaque formation in arteries. Antithrombotic agents, including aspirin and anticoagulants, prevent blood clots by inhibiting platelet aggregation and the coagulation cascade. These treatments are essential for CVD patients as they address key mechanisms like high blood pressure, cholesterol buildup, and thrombosis, which are critical in preventing heart attacks, strokes, and other cardiovascular events.

Development of New Antithrombotic Regimens for Patients with Acute Coronary Syndrome.Epidemiology, pathophysiology and contemporary management of cardiogenic shock - a position statement from the Heart Failure Association of the European Society of Cardiology.New insights into cardiovascular disease in patients with Kawasaki disease.