Search Results within category "Heart & Vascular"
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A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial
The dal-GenE trial is evaluating the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with a documented recent heart attack or hospitalization due to severe coronary artery disease. Dalcetrapib is an investigational drug (not approved by the United States Food and Drug Administration) that has been evaluated in several large clinical trials, most notably dal-OUTCOMES, a study of over 15,000 patients which was designed to evaluate its effect in patients with recent ACS. The results of this large study demonstrated that treatment with dalcetrapib did not change the risk of cardiovascular disease in the majority of patients with recent ACS. However, after the study was over, researchers identified a group of patients that had a significant benefit. Specifically, the group of patients who had a particular variant (AA) of a gene that all humans share (ADCY9) had their risk of having another cardiovascular event reduced by 39%. Approximately 1 in 5 patients studied had this genetic variant.
Those individuals with the AA variant of the will continue in the study and will be started on study drug 4-12 weeks after their index event.
Kevin Gardner at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-6508
All
18 year(s) or older
NCT02525939
Heart & Vascular
Crest-2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
To assess if the proportion of patients with a primary event differs between patients treated with intensive medical management alone compared to CEA, or to CAS, in patients with high grade asymptomatic carotid stenosis.
To assess whether intensive medical management differs from CEA and from CAS to maintain the level of cognitive function at 4 years of follow up
To assess if there are treatment differences in major stroke, minor stroke, disabling stroke and tissue based stroke at 4 years, using an analytic approach identical to that for the primary aim.
To assess if the CEA or CAS versus intensive medical management difference is affected by patient age, sex, severity of carotid stenosis, restenosis, risk factor level and during of the asymptomatic period
Deborah Hoffman at dhoffman1@pennstatehealth.psu.edu or 717-531-0003, ext=283063
All
18 year(s) or older
NCT02089217
Heart & Vascular, Neurology
Penn State Hershey Sitting and Health Study
This study aims to examine the effect of pedaling a compact elliptical device at the desk on employees' work productivity. This study also aims to evaluate the effect of different types of incentives on promoting desk-based pedaling.
Liza Rovniak at activitystudy@psu.edu
All
18 year(s) or older
NCT03274635
Heart & Vascular, Prevention, Mental & Behavioral Health
Role of microRNA activation of lectin-like oxidized LDL receptor (LOX-1) mechanisms in microvascular dysfunction in women with endometriosis
Endometriosis is a gynecological disorder associated with chronic pelvic pain, pain during intercourse, and infertility. With endometriosis, endometrium-like tissue is found in sites outside the uterine cavity. This disorder affects 6% - 10% of women of reproductive age. It can be as high as 35-50% in women who have pain or infertility. Endometriosis is associated with higher risk of hypercholesterolemia and hypertension that increases risk for cardiovascular disease (CVD). CVD is characterized by dysfunction of the blood vessels of the body. CVD is the leading cause of death in women.
Two groups of women complete this study: 1) healthy women between the ages of 18 and 45 years (Controls); 2) women between the ages of 18 and 45 years with endometriosis. The screening and two experiments include blood draws. After passing a medical screening, each subject participates in a microdialysis (MD) experiment before and after 6-9 days of oral atorvastatin therapy (10mg/day). Atorvastatin (brand name: Lipitor) is an FDA-approved drug that physicians prescribe to lower blood cholesterol. The atorvastatin also suppresses substances made by the body that increase the risk of CVD. MD is a procedure in which a thin tube of membrane that mimics a capillary blood vessel is implanted in the skin. Substances of interest are added to the saline flowing through the MD sites and are delivered into small areas of skin. The MD experiments combine the perfusion of the test-substances with local heating of the skin to explore the causes for the dysfunction of blood vessels and increased risk for CVD that occurs with endometriosis.
Susan Slimak at sks31@psu.edu or 814-863-8556
Female
18 year(s) or older
N/A
Heart & Vascular, Pregnancy & Infertility, Women's Health
Story Circles as a Methodology: Exploring Illness Perceptions in Advanced Heart Failure
We will utilize Story Circles with persons living with advanced heart failure to explore their experiences, their illness perceptions, and how these perceptions might influence goals of care and decision making. There is a gap in our current understanding of how persons living with an advanced life-limiting illness such as heart failure perceive their illness and how this might influence decision-making. New knowledge regarding a person’s illness perceptions has important implications for future work including goals of care conversations and decision making for heart failure throughout the illness trajectory and especially at the end of life.
Lisa Kitko at lkitko@psu.edu or 814-863-2228
All
18 year(s) or older
N/A
Heart & Vascular
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit in Subjects with Hypertension
The purpose of this study is to evaluate the safety and effectiveness of renal denervation while still on blood pressure medications. Renal denervation is the destruction of nerve fibers that run along the kidney blood vessels. This causes an interruption of nerve signals that may cause high blood pressure. Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces blood pressure.
Paula Trump at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5967
All
18 year(s) or older
NCT02910414
Heart & Vascular
Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome
Postural tachycardia syndrome (POTS) is a chronic syndrome in which the heart beats too quickly when standing. POTS primarily affects young women. People with POTS also experience symptoms such as feeling faint, fatigue, nausea, and mental clouding or "brain fog." “Brain fog” is one of the most bothersome symptoms of POTS and it is unknown why people with POTS experience this symptom. Some studies have shown that POTS patients have problems with attention, memory and executive function (ability to plan, organize information, and adapt to changes) while seated and when upright. In this study, we will evaluate how brain function during mental tasks is affected in people with POTS compared to healthy volunteers. All volunteers will complete mental tasks while lying down and standing. If eligible, we will measure brain activity using functional magnetic resonance imaging (fMRI).The findings from this study will increase our understanding of the mental complaints in people with POTS, to hopefully help with development of new treatments.
Amanda Miller at aross1@pennstatehealth.psu.edu or 717-531-7676
All
18 year(s) or older
NCT04137757
Heart & Vascular, Neurology
Effects of heating on exercise pressor reflex in peripheral artery disease: Exercise Ability
To determine if the sympathetic and blood pressure (BP) responses to exercise will be attenuated during and after heat exposure in patients with peripheral artery disease (PAD).
Cheryl Blaha at cblaha@pennstatehealth.psu.edu or 717-531-1605
All
18 year(s) or older
N/A
Heart & Vascular
Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)
The GUIDE-HF Randomized arm is to determine if PA pressure-guided HF management using CARDIOMEMS improves health outcomes in NYHA Class II, III or IV heart failure patients with either elevated NT-proBNP and/or a prior heart failure hospitalization.
The GUIDE=HF Single Arm is to determine the equivalence of the effect of PA pressure-guided HF management on health outcomes between NYHA Class III heart failure patients with elevated NT-proBNP only and those with a prior heart failure hospitalization only.
Katie Loffredo at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-6855
All
18 year(s) or older
NCT03387813
Heart & Vascular
Site For Trial to Access Chelation Therapy TACT2
Site For Trial to Access Chelation Therapy TACT2
Katie Loffredo at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5825
All
18 year(s) or older
NCT02733185
Heart & Vascular, Diabetes & Hormones
Experimental determination of the neurogenic contribution to skin flowmotion
The purpose of this study is to use spectral analysis to measure blow flow changes in superficial vessels of the arm.
This study will explore how skin blood flow changes in response to heat and nerve inhibition. We will be locally heating the skin and blocking nerves of the skin with a topical numbing cream and measuring the resulting skin blood flow.
Skin blood flow is measured by a machine that shines a harmless laser light onto the skin. The machine produces a signal that looks like a wave moving up and down. There is a known, and previously used, algorithm that can identify the neurogenic input-wave from the total skin blood flow-wave.
Zachary Lichter at zzl5229@psu.edu or 814-863-8557
All
18 year(s) or older
N/A
Heart & Vascular, Neurology
Angiotensin-(1-7) and Energy Expenditure in Human Obesity
We will investigate the effects of the hormone angiotensin-(1-7) on energy expenditure in patients with obesity.
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
NCT03777215
Heart & Vascular, Diabetes & Hormones
Assessing the Feasibility of Implementing a Storytelling Intervention among African Americans with Hypertension: A Pilot Study
Personal narratives or storytelling is an approach that has been used to promote healthy behaviors among people with diabetes, breast cancer, and high blood pressure. There is a need for low-cost, culturally-tailored interventions that promote healthy behaviors and improve health outcomes in the African American community. The objective of this project is to develop a storytelling intervention for African Americans with high blood pressure. Participants will be filmed sharing their experiences living with high blood pressure, and the videos will be shared with other African Americans with high blood pressure. We are recruiting 6-8 African American adults with high blood pressure, age 18-80, that have been diagnosed with high blood pressure and are taking medications to manage high blood pressure.
Yendelela Cuffee at ycuffee@phs.psu.edu or 717-531-7178
All
18 year(s) or older
N/A
Heart & Vascular
The Muscle Reflex: Limb blood flow
We will examine whether blood flow responses to exercise (in exercising and non-exercising legs) are different between patients with PAD and healthy subjects.
Cheryl Blaha at cblaha@pennstatehealth.psu.edu or 717-531-1605
All
18 year(s) or older
N/A
Heart & Vascular
Effects of heating on exercise pressor reflex in peripheral artery disease: Sympathetic Response
The purpose of this study is to examine if nervous system and blood pressure responses to exercise will be less with heat exposure in patients with peripheral artery disease (PAD) and healthy controls.
Cheryl Blaha at cblaha@pennstatehealth.psu.edu or 717-531-1605
All
18 year(s) or older
N/A
Heart & Vascular
Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension
The purpose of this study is to see if the hormone angiotensin-(1-7) improves the function of blood vessels and lowers blood pressure in obese subjects with hypertension.
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
NCT03604289
Heart & Vascular
Postmenopausal women and their endothelium: Is dietary nitrate supplementation protective?
Heart disease is the leading cause of death in the United States. The loss of estrogen from menopause puts women at a greater risk of developing heart disease.
The purpose of this study is to determine the effects of drinking beetroot juice on measures of blood vessel health and blood pressure. Participants will drink beetroot juice and placebo juice each for one week followed by blood pressure measurements and ultrasound imaging of an artery in the upper arm.
Jocelyn Delgado at jmd956@psu.edu or 408-679-8390
Female
18 year(s) or older
NCT03644472
Food & Nutrition, Heart & Vascular, Women's Health
Site For CLOVERS
Site For CLOVERS
Nancy Campbell RN at ncampbell1@pennstatehealth.psu.edu or 717-531-1707, ext=3
All
18 year(s) or older
NCT00343402
Infectious Diseases & Immune System, Heart & Vascular
Modulating Role of Vitamin D in Oxidative Stress-Induced Vascular Dysfunction
Cardiovascular disease (CVD) is a leading cause of sickness and death. Studies have shown higher risk of CVD in African Americans (AA). The reasons for this higher risk are not well understood. Vitamin D may play a role in blood vessel health and reduce risk of CVD. Darker skin absorbs light from the sun, and reduces the amount of vitamin D made by the body. We think that lower vitamin D in AA may lead to reduced blood vessel health and increased risk of CVD. We also think that risk of low vitamin D levels in those with increasingly darker skin pigmentation may predispose them to vascular dysfunction over time. This study will look at differences in nitric oxide that helps blood vessels relax across individuals with a wide range of skin pigmentation. We will also look at “oxidant stress,” which can reduce nitric oxide.
In this study, we will examine the function of blood vessels in the skin. The blood vessels in the skin are a model for blood vessels in other organs in the body. We will also look at the function of other, larger blood vessels in the body.
This research is being done to find out why blood vessel function is reduced in young AA adults who are healthy, and to determine if reduced vitamin D in those with darker skin may cause reduced blood vessel function. The research is also being done to find out if vitamin D will improve blood vessel function. Approximately 30 people will take part in this study at the Noll Lab.
Tony Wolf at saw85@psu.edu or 814-863-8556
All
18 year(s) or older
N/A
Heart & Vascular
A double-blind randomized placebo-controlled study on the analgesic properties of amiloride in exercise-induced skeletal muscle pain
To determine if the drug Amiloride will reduce exercise related muscle pain and improve exercise tolerance in healthy volunteers.
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
N/A
Heart & Vascular
The changes in insulin resistance and metabolic health among young, middle aged, and older adults meeting the current aerobic exercise training recommendations.
The overall purpose of this research is to evaluate the difference the national cardiorespiratory exercise recommendations have on metabolic and cardiovascular health over 6 weeks in previously sedentary young, middle aged, and older adults matched for obesity. The participants will complete moderate intensity exercise for 30 minutes per day, 5 days per week for 6 weeks. Pre- and post-intervention testing will be completed to evaluate changes in metabolic and cardiovascular health.
Nicole Gilbertson at nmg46@psu.edu or 814-949-5016
All
18 year(s) or older
N/A
Heart & Vascular, Sports Medicine, Diabetes & Hormones
Site For Habitual Diet and Avocado Trial (HAT)
Site For Habitual Diet and Avocado Trial (HAT)
Kristin Davis at kmd74@psu.edu or 814-863-0856
All
18 year(s) or older
N/A
Food & Nutrition, Heart & Vascular
The role of nuclear factor from activated T-cells (NFAT) in microvascular dysfunction
High blood pressure can lead to cardiovascular disease (CVD). CVD is a leading cause of illness and death in the United States. This research explores some of the ways high blood pressure impairs blood vessel function. This study uses minimum-risk procedures (flow meditated dilation, skin biopsy, and microdialysis) to explore the mechanisms underlying the impaired blood vessel function. We conduct experiments before and after 7-day treatment with FDA-approved drugs Telmisartan (prescribed to treat high blood pressure) and Tacrolimus (prescribed to treat eczema). The results of this study could suggest new ways to diagnose and treat high blood pressure.
The expression of NFAT isoforms are altered in essential hypertensive vascular tissue and that short term telmisartan decreases NFAT-mediated cytokine production in hypertensive adults. We predict that 10 days of Telmisartan will alter the expression profiles of NFATc1 and NFATc3 and improve endothelial function and vascular smooth muscle cell responsiveness.
Susan Slimak at sks31@psu.edu
All
18 year(s) or older
N/A
Heart & Vascular
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF)
This is a registry based clinical trial to assess whether the initiation of spironolactone plus standard of care compared to standard care alone improves outcomes in patients with heart failure with preserved ejection fraction.
All
18 year(s) or older
NCT02901184
Heart & Vascular
The effects of local negative pressure on forearm and skin blood flow in humans
This study continues our exploration into the mechanisms underlying the control of blood flow. During the experiments, we noninvasively measure skin blood flow (SkBF) and forearm blood flow (FBF) with a FLPI and venous occlusion plethysmography (VOP), respectively. The FLPI uses a low energy laser to measure SkBF. VOP uses blood pressure cuffs on the upper arm and wrist, and an elastic strain gauge encircling the forearm between the cuffs to measure the change in forearm-circumference over time from which we calculate FBF. For each experiment, we collect SkBF and FBF data for a 20-minute baseline, expose the skin of the forearms to negative pressure and then collect SkBF and FBF data for an additional 30-90 minutes. Each subject participates in 2 experiments that differ only in the protocol for the application of negative pressure (i.e. continuous, pulse).
Gabie Dillon at gad27@psu.edu
All
18 year(s) or older
N/A
Heart & Vascular
The effect of pistachios on blood sugar control, heart and gut health
The purpose of the study is to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.
Terry Riley at tmr359@psu.edu or 866-778-3438
All
18 year(s) or older
NCT04056208
Food & Nutrition, Heart & Vascular
The Muscle Reflex: MRI Studies
This research is being done to examine how the response to leg exercise measured with MRI is different between patients with Peripheral Arterial Disease (PAD) and healthy volunteers.
Cheryl Blaha at cblaha@pennstatehealth.psu.edu or 717-531-1605
All
18 year(s) or older
N/A
Heart & Vascular
Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms (ALIVE)
The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of left ventricular antero-septal aneurysms/scars in patients with symptomatic heart failure due to a previous heart attack.
If you have heart failure due to a previous heart attack, you can discuss with your primary cardiologist the location of your scar tissue, or you can discuss this study with a member of the study team who can have your echocardiogram reviewed by one of the study doctors.
All
18 year(s) or older
NCT02553785
Heart & Vascular
The peripheral vascular effects of sulfhydryl-containing antihypertensive pharmacotherapy on microvascular function and vessel remodeling in hypertensive humans
High blood pressure can cause physical changes to the blood vessels of the body (remodeling). If a person who has high blood pressure also has a lot of blood vessel remodeling with their condition, they are more likely to have poor results with medical treatment for hypertension. We examine the impact of different classes of drugs that doctors use to treat high blood pressure (hypertension) on blood vessel remodeling. Some drugs that doctors prescribe for their patients contain a “sulfhydryl group” (a sulfur atom bonded to a hydrogen atom). Drugs that have the sulfhydryl group may reduce blood vessel remodeling more that drugs that do not. For this study, participants who have high blood pressure perform the experiments, take a drug for 16-weeks to lower blood pressure, and repeat the experiments. We randomly assign one of three drugs to participants who have high blood pressure: a diuretic (“water pill”), a drug containing a sulfhydryl group, or a drug that does not contain a sulfhydryl group. Participants who do not have high blood pressure perform the experiments, but do not take any of the drugs. In some of our experiments, we use a technique called “microdialysis” (MD). With MD, we perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. We also analyze very small skin samples (skin biopsy) obtained from the forearm. Lastly, we use a standard technique called “flow mediated dilation” (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
NCT03179163
Heart & Vascular
REducing Lung congestion symptoms using the V-wavE shunt in advanced heart failure (RELIEVE-HF)
The objective of the study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk group of symptomatic patients suffering from heart failure.
All
18 year(s) or older
NCT03499236
Heart & Vascular