Treatment Trials

23 Clinical Trials for Various Conditions

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RECRUITING
Sympathetic Regulation of Large Artery Stiffness in Humans With ISH
Description

Stiffening of your blood vessels, particularly the large vessels from your heart (called the aorta and carotids) you age contributes to the development of cardiovascular disease (CVD) such as heart attack and stroke. Nerve activity from your brain to your body also increases with advancing age but it is unknown if this nerve activity contributes directly to the stiffening on your blood vessels in older adults in addition to high blood pressure. Therefore, successful completion of the proposed aims will have a significant clinical impact by identifying if nerve activity from your brain could be a novel target for therapies that would lower stiffness of the aorta and carotid arteries in older adults.

COMPLETED
Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males
Description

It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. Given the fact that obesity is associated with an impaired function of eNOS, the effect of chronic dietary GSE supplementation on abnormal blood pressure response to exercise and aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Q, and aortic stiffness at rest and during exercise. This study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.

COMPLETED
Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest
Description

This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

Conditions
COMPLETED
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction
Description

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.

COMPLETED
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Description

The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.

COMPLETED
RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors
Description

Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer, occurring at a significantly younger age than in the general population. The increased incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover, understanding of the mechanisms by which cancer treatment could influence the occurrence of latent cardiovascular events is unavailable. Our group and others have established independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes, cardiac death, and congestive heart failure. The goal of this application is to show that childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health have increased aortic stiffness, when compared to healthy adolescent and young adult age mate. Studies are designed to determine if MRI measures of cardiovascular function differ between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The investigators propose that MRI markers responsible for cardiovascular events represent new clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.

RECRUITING
Causal Mechanisms in Adolescent Arterial Stiffness
Description

Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.

COMPLETED
Management of Cardiovascular Disease in Kidney Disease (MaCK) Study
Description

Cardiovascular disease (CVD) is the largest concerns for patients with Chronic kidney disease (CKD). At present time the investigators do not have proven effective strategies to reduce high CVD related deaths in CKD. This study assesses a novel therapy (hydroxychloroquine, HCQ) for the treatment of CVD in patients with CKD. This is the first human proof-of-concept study and is planned to be conducted among US Veterans, who suffer from both CKD and CVD at a disproportionately greater rates. The outcome of this study has the potential to provide an entirely new line of therapy for the treatment of CVD in CKD.

RECRUITING
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
Description

This study will examine the potential cardiovascular effect(s) of artificial pancreas (AP) technology in patients with type 1 diabetes. AP technology is a system of devices that closely mimics the glucose-regulating function of a healthy human pancreas. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, the investigators will research whether improvements in blood glucose levels and blood glucose variability will in turn decrease biomarkers of inflammation and endothelial dysfunction while improving cardiovascular function.

Conditions
COMPLETED
Targeting Inflammation to Treat Cardiovascular Aging
Description

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States with older age being a primary risk factor. The number of adults greater than age 65 years will almost double to 70 million by 2030, therefore identifying therapeutic strategies for treating or preventing age-related disorders in humans is of major biomedical importance. Cardiovascular aging, defined as a reduction in vascular and cardiac functions with normal aging, occurs even in the absence of CVD risk factors and overt CVD. A key feature of cardiovascular aging is stiffening of the large elastic central arteries such as the aorta. This is important because aortic stiffness directly contributes to clinical problems such as increased blood pressure, reduced blood flow to the heart muscle, and thickening of the heart muscle. Therefore, these clinical consequences are hypothesized to mediate a substantial proportion of the increase in CVD risk in older adults. However, effective drug treatments for aortic stiffness are not currently available and the biological reasons (mechanisms) involved in causing aortic stiffening remain undefined. In addition, the inability of smaller blood vessels to relax, impairment of the heart to relax during the filling phase of the heart cycle (i.e., diastole), and increased blood pressure variability, have all been linked to aortic stiffness. Furthermore, chronic low-grade inflammation with advancing age has been proposed to be a common mechanistic link (i.e., biological reason) between these reductions in cardiovascular function in older adults. Therefore, the investigators propose that inflammation could be a novel therapeutic target to treat cardiovascular aging in older adults. Our central hypothesis is that inflammation mediates the age-related deterioration in cardiovascular functions observed with advancing age through the development of oxidative stress (i.e., imbalance between damaging oxygen free radicals vs. protective antioxidants). Our hypothesis predicts that chronic inhibition of inflammation with Salsalate, an FDA-approved anti-inflammatory drug similar to aspirin that is used to treat rheumatoid arthritis pain and known to inhibit the 'master' regulator of inflammation in the cell (i.e., nuclear factor kappa B), will improve cardiovascular function in older adults. In addition, the investigators hypothesize that the mechanism for the improvement in cardiovascular function during inhibition of inflammation will be by suppressing oxidative stress. To test our hypothesis, the investigators will randomize older healthy adults (age 50-79 years) to 3 g/day of salsalate or placebo (i.e., pill with inactive substance) pills for 4 weeks and have cardiovascular function measured at baseline and again after 4 weeks.

TERMINATED
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Description

People with type 2 diabetes experience heart failure more often than do people without diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This study will examine whether exenatide, a medication used to treat diabetes, may have beneficial effects on the heart in people with type 2 diabetes and heart failure.

COMPLETED
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
Description

Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often present, and can be a predictor of aortic dilation and cardiovascular complications. In addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and logical therapeutic targets in adults with Marfan syndrome. TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic stiffness and improves diastolic function in hypertension, renal disease and hypertrophic cardiomyopathy. This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and echocardiography for diastolic function will be performed at the beginning and end of treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation will also be performed at 0 and 6 months. We plan to determine whether losartan decreases aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.

Conditions
COMPLETED
Impact of Arterial Stiffness and Central Aortic Blood Pressure on Kidney Transplant Outcomes
Description

People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this increased risk is complex but there is strong evidence that changes in arterial stiffness play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is significantly associated with the future risk of clinical events. In addition, aPWV is an independent and powerful predictor of all-cause and cardiovascular mortality in patients on dialysis. Reduction of aPWV, mainly by use of an angiotensin converting enzyme (ACE)-inhibitor results in an improved survival in dialysis patients. These findings suggest that arterial stiffness is not merely a marker of arterial damage but a potentially reversible factor contributing to mortality in dialysis patients. There is strong evidence that arterial stiffness increases as glomerular filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a number of studies as a significant risk factor for CKD progression. In addition to arterial stiffness, elevated central aortic blood pressure and central pulse pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood pressure is more strongly related than standard BP measured at the brachial arteries (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery hypertrophy as well as to future cardiovascular events. Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although, successful kidney transplant has been shown to improve arterial stiffness post-transplant, we do not know to what extent the pre-transplant arterial stiffness and central aortic blood pressure and their improvement post-transplant impact the cardiovascular and allograft outcomes. In addition, it is unclear what transplant related factors are associated with improvement in arterial stiffness and central aortic blood pressure post-transplant. The goals of our study are: 1. To determine if pre-transplant central blood pressure and aortic stiffness impact post-transplant cardiovascular and kidney allograft outcomes. 2. To determine whether the changes in central blood pressure and aortic stiffness post-transplant impact cardiovascular and kidney allograft outcomes. 3. To determine the factors associated with improved central aortic blood pressure and arterial stiffness post-transplant.

ACTIVE_NOT_RECRUITING
Trial of Exercise in Aortic Dissection Survivors
Description

The primary objective of this study is to test the safety and mental health benefits of a guided exercise program for people who survived an acute aortic dissection. This study is designed to answer several questions: 1. Can supervised exercise improve confidence and mental health in dissection survivors?; 2. How safe are different types of exercise for people who are living with severe aortic disease?; 3. Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?; 4. Does the blood pressure response to exercise predict risks for aortic enlargement or dissection in unique ways that other tests may not detect? The long-term goal of this research is to develop new guidelines for exercise and daily activities that promote the safety and well-being of all TAD patients. All participants will be required to: * Complete online questionnaires (demographic survey, 2009 Behavioral Risk Factor Surveillance Survey, the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) v2.0 profile questionnaire) * Exercise (\>150 minutes/week) * Receive all usual clinically indicated care, including diagnostic tests and medications. Recommendations for tests or interventions will not change based on the assigned study arm. Participants who are randomized to guided exercise group will undergo initial training that consists of: one video demonstration, one exercise training session or group session, one follow up home visit, and virtual check-ins. Participants who are randomized to usual care will attend routine clinic visits but will not receive any teaching or supervision and will not participate in any in-person or virtual exercise sessions. Instead, they will receive standardized counseling about exercise, including an exercise pamphlet that is given to all TAD patients.

COMPLETED
Aortic-Radial Pressure Gradients Post CPB
Description

This study will examine whether pre-operative, non-invasive arterial stiffness measurements can be used to predict which patients will develop an aortic-to-radial pressure gradient after coronary artery bypass graft (CABG) surgery. A previous small study by Kanazawa, et al. demonstrated in patients who developed an aortic-to-radial pressure gradient after CABG surgery, the pulse wave velocity (PWV) was higher in the aorta and decreased when moving toward the radial artery. In the patients who did not develop a pressure gradient, the PWV started lower in the aorta and increased when moving towards the periphery. The purpose of this investigation is to examine whether pre-operative PWV measurements can be used to identify patients who will develop an aortic to radial pressure gradient after CABG surgery. Applanation tonometry will be performed on the right carotid and femoral arteries to assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system, AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of general anesthesia in the presurgical area. Also in the presurgical area, a non-invasive cardiac output (CO) measurement will be obtained by using the ICON Device (Osypka Medical, La Jolla, California). This CO value will be used to compare to the CO values obtained invasively in the operating room.

RECRUITING
Impact of Elastin Mediated Vascular Stiffness on End Organs
Description

Background: People with Williams Syndrome (WS) and supravalvular aortic stenosis (SVAS) have less elasticity in their blood vessels. This is called blood vessel stiffness. Blood vessels may have focal narrowings called stenoses or may just be globally more narrow. Objectives: Researchers want to see how blood vessel differences in people with Williams Syndrome and supravalvular aortic stenosis affect organs in the body including the heart, gut, kidneys, and brain. Eligibility: People ages 3-85 who have WS or SVAS Healthy volunteers ages 3-85 Design: * Participants will have yearly visits for up to 10 years. All participants will be offered the same tests. * Participants will give consent for the study team to review their medical records. If the participant is a child or an adult with WS, a parent or guardian will give the consent. * Participants will visit the NIH where they will have a physical exam and medical history. Based on their health history, participants will undergo a series of imaging tests and measures of blood vessel function over the course of 2-4 days. Tests of cognitive abilites will also be performed. Blood will be drawn and an IV may be placed for specific tests.

RECRUITING
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Description

Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound vibration via a speaker placed outside the scan room which is connecting plastic drum via a plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft tissues such as liver, heart, kidneys, breast etc.

COMPLETED
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
Description

The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

Conditions
COMPLETED
Watermelon Supplementation and Arterial Stiffness
Description

Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main risk factors for the metabolic syndrome. Approximately 60% of adults in the United States are prehypertensive or hypertensive. Hypertension has been associated with abnormal endothelial and autonomic function, the two main mechanisms of BP regulation. Endothelial dysfunction, as a result of reduced NO (a vasodilator), and increased sympathetic nervous system activity contribute to arterial stiffness by enhancing the vasomotor tone. Because BP variations are sensed by baroreceptors in the wall of large arteries, increased stiffness of arteries may attenuate the control of BP by the autonomic nervous system leading to hypertension. High production of proinflammatory cytokines and low adiponectin (vascular protective molecule), are considered the underlying mechanisms leading to endothelial dysfunction and arterial stiffness. The recommended intervention for controlling BP in overweight/obese individuals with pre- and stage 1- hypertension is lifestyle modifications and not drug therapy. Among the dietary regimens that are reported to reduce BP is L-arginine, the substrate for endothelial NO production. Recently, oral L-citrulline has been shown to be more effective than L-arginine in improving circulating NO levels because is not affected by enzymatic degradation. Watermelon, the leading US melon crop, is one of the few natural foods rich in L-citrulline which is efficiently transformed to arginine in humans. The investigators long-term goal is to provide feasible and effective dietary ways to reduce cardiovascular risk factors in individuals with high abdominal fat and BP. The overall objective of this study is to bring forth evidence that watermelon supplementation will reduce BP and cardiovascular risk factors such as arterial stiffness, autonomic dysfunction and endothelial dysfunction. The investigators postulate that watermelon supplementation will reduce BP and arterial stiffness by enhancing endothelial function and reducing vascular inflammation. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating obesity-related hypertension at its early stage which does not require drug therapy.

Conditions
COMPLETED
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
Description

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

COMPLETED
Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation
Description

Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?

COMPLETED
The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes
Description

The purpose of this study is to examine the effect of 4 weeks of Citrulline supplementation on macro- and microvascular function during acute hyperglycemia in middle-aged and older adults with type 2 diabetes.

Conditions
COMPLETED
Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension
Description

Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness. The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.

Conditions