Search Results within category "Heart & Vascular"
Search all categoriesSuggestions within category "Heart & Vascular"
Establishing a Normal Database for Comparison to Specialized Populations; Oxygen consumption
This study located in Hershey, PA, will examine the cardiovascular and respiratory responses to exercise testing on a treadmill, stationary bike or arm bike to determine overall aerobic fitness capacity. This will contribute to a database of healthy adults to compare to persons with disabilities.
Kristin Slavoski at PMR_research@pennstatehealth.psu.edu or 7175310003 x283816
All
18 year(s) or older
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N/A
Exercise in Genetic Cardiovascular Conditions. Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM", Lifestyle and Exercise in Long QT Syndrome: "LIVE-LQTS"
To compare the composite risk of death, cardiac arrest, ventricular arrhythmias, or syncope in patients with hypertrophic cardiomyopathy or the long QT syndrome who are participating in moderate or vigorous exercise with sedentary patients.
Sharon O'Brien at sobrien@pennstatehealth.psu.edu or 717-531-5966
All
18 year(s) or older
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NCT02549664
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
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NCT02525939
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 x283063
All
18 year(s) or older
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NCT02089217
A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)
A drug study to test the safety and effectiveness of a new drug for heart failure.
Megan Eaton at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5825
All
18 year(s) or older
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NCT02861534
Role of angiotensin II and inflammation in persistent vessel dysfunction following preeclampsia
The purpose of this study is to determine what contributes to blood vessel damage during and immediately following a preeclamptic pregnancy. To do this, we examine blood vessel function in the small vessels in the skin. Understanding what contributes to these impairments may lead to better treatments and/or prevention strategies for vessel dysfunction in women who have or had preeclampsia.
Two groups of subjects will be enrolled in this study: women who have delivered within 1 year and who have had a preeclamptic pregnancy diagnosed by their obstetrician, and women who have delivered within 1 year and did not have preeclampsia.
Susan Slimak at sks31@psu.edu or 814-863-8556
Female
18 year(s) or older
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NCT03482440
Cheese Consumption and Human Microvascular Function
The human body controls the amount of blood flowing through healthy blood vessels. The body performs this vital function by changing the diameter of the blood vessels. The way the body controls blood flow can be different with age and the presence of some diseases such as hypertension (high blood pressure). One of the first signs of a disease that affects blood vessels is a change in the function of the very small blood vessels (microcirculation) of the skin. Studying blood flow control in the skin’s blood vessels helps researchers to learn about the onset and effects of, and develop treatments for diseases that affect blood vessels.
Dietary sodium can impair the function of the microcirculation in the skin. This study’s goal is to determine if and how natural cheese may protect against impairments in the function of the microcirculation caused by sodium in an otherwise healthy older people. We conduct a study in which participants eat cheese (6 servings/day) or no cheese during a 7-day low-sodium or high-sodium base-diet. Our approach uses methods specific to the microcirculation to examine how sodium causes human microcirculation impairment and the potential protective effects of natural cheese. Also, we measure blood biomarkers and the function of larger blood vessels to examine the effects of cheese on overall vascular health.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
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NCT03376555
Mechanisms of neurovascular dysfunction in psoriasis patients
The purpose of this study is to determine what leads to blood vessel and nervous system dysfunction and the increased risk of cardiovascular disease in adults with psoriasis. Psoriasis is an independent risk factor for cardiovascular disease, because cardiovascular disease and psoriasis share common underlying inflammatory causes. This study may lead to treatment and/or prevention strategies to reduce cardiovascular disease risk in psoriasis patients. We explore 1) changes in nitric oxide that could make the body less able to relax blood vessels and 2) changes in sympathetic nervous system function that may contribute to increased cardiovascular disease risk in psoriasis patients. We will investigate the effect of oral salsalate administration on neural and blood vessel function in adults with psoriasis. The study includes experiments that examine blood vessel function in small vessels in the skin and nerve activity in the leg.
Billie Alba at bka125@psu.edu or 814-863-8557
All
18 year(s) or older
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N/A
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
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NCT03274635
Cyclic Variation in Micronutrient Concentrations and Plasma Volume in Reproductive-Age Women
In this study, we will examine how the menstrual cycle influences micronutrient concentrations in women of reproductive age. We will also examine how the menstrual cycle affects plasma volume in these women. Finally, we will assess the relationship between plasma volume and micronutrient concentrations among study participants. This study involves three visits to the Clinical Research Center (CRC) located in Noll lab, University Park. To participate, interested women will contact the study coordinator via phone or email and provide their name and phone number.
A member from the PI lab will contact the interested participant to screen her for eligibility. If a participant is eligible, she will be scheduled to visit the CRC, where eligibility will be confirmed. To confirm eligibility, we will measure her weight, height, blood pressure and conduct a pregnancy test. If eligible, we will conduct hydration test, and measure body composition, then she will complete a short questionnaire about her pregnancy histories and health. She will then rest on bed for 15 to 20 minutes and the nurse will insert an IV to draw some blood ~15mL. Then the nurse will inject her with a small amount of a green dye followed by a series of blood draws (total ~15mL) within the next 5 minutes.
She will relax on the bed or sit on a chair for 15 minutes to be monitored by the nurse, to be sure that she is okay. Then we will provide her with a home-based fertility monitor to be used to track her menstrual cycle. We will instruct her on how to use her urine sample to track daily changes in some targeted reproductive hormones during the cycle. The results are displayed in a simple to read format from the monitor. We will use the readings from this monitor to schedule visit 2 (~ day 12 of her cycle). After visit 2, the participant will conduct a few more urine test at home and the results of those tests will be used to schedule her final last visit (~ day 21 of her cycle). On the 2nd and 3rd visits, we will again measure her weight, height, blood pressure and conduct pregnancy to confirm that the participant is still eligible. If we confirm she is still eligible, we will complete the rest of the measurements as in visit one. Blood samples at each visit will be processed and stored at -80C until the data collection is completed. Plasma samples will be processed same day to determine the subject’s plasma volume.
Sixtus Aguree at sua204@psu.edu or 814-867-5938
Female
18 year(s) or older
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NCT03422809
The effect of fatigue on the exercise pressor reflex
This research is being done to find out if fatigue effects the body's response to exercise.
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
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N/A
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
Show full eligibility criteria
N/A
A multi-site randomized clinical trial to compare healthy eating recommendations for six months on changes in visceral adiposity in overweight/obese Americans
The purpose of the Habitual Diet and Avocado Trial (HAT) is to determine whether eating avocados has an impact on decreasing body fat in adults. Consumption of avocado has been linked to a variety of health benefits, but much of this research has been for short periods of time and in small samples.
Kristin Davis at kmd74@psu.edu or 814-863-0856
All
18 year(s) or older
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N/A
The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction
We propose to conduct a 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation & immune function, and diet satisfaction in participants at risk for CVD. The three test diets that will be fed to the study participants are: a Low Spice Diet (SD-Low; < 0.5 g/day of all spices); a Moderate Spice Diet (SD-Mod; 3 g/day of all spices, which approximates average spice intake in the U.S.); and a Culinary Spice Diet (SD-Culinary; 9 g/day of all spices). All three diets will be based on an Average American Diet (AAD), which will be designed to represent the usual dietary intake in U.S. The test diets will be designed to provide approximately 32% calories from fat (which reflects current total fat intake), 11% of calories from SFA and 3400 mg/day of sodium. The SD-Culinary will provide a culinary quantity of spices, 9 g/day per 2000 calories (which is 3 times the average spice consumption in the U.S.). All test diets will be designed with the same foods but will only vary in the quantity of spices provided. All test diets will be fed for 4 weeks each followed by a minimum 2-week break between test diets (during which time participants will follow their self-selected habitual diets). The spices will be incorporated into familiar foods in a highly palatable manner. The objective of the present study is to evaluate the effects of a spice blend on major CVD risk factors (LDL-C, BP, vascular health, inflammation and oxidative stress), as well as diet satisfaction.
Kristina Petersen at kup63@psu.edu or 814 863 8622
All
18 year(s) or older
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NCT03064932
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
The study is looking to find out more about how an investigational study drug called omecamtiv mecarbil works in people with heart failure. Omecamtiv mecarbil is also known as AMG 423. Omecamtiv mecarbil is an investigational medicine that increases the heart’s ability to pump.
Kevin Gardner at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5825
All
18 year(s) or older
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NCT02929329
Echocardiographic Imaging of Cardiac Performances in Spinal Cord and Non-Spinal Cord Injury Adults (A Pilot Study)
This research is being done to assess if spinal cord injury patients’ impaired nervous system will lead to changes in heart function during changes in body position. Additionally, the study will compare the tetraplegic, paraplegic, and able-bodied individuals’ measurements of heart function variables during different body positions.
Kristin Slavoski at PMR_research@pennstatehealth.psu.edu or 7175310003 x283816
All
18 year(s) or older
Show full eligibility criteria
N/A
The effect of hyperoxia on coronary arterial collateral circulation
To examine the effect of 100% oxygen on the coronary blood flow of patients with coronary artery disease
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
Show full eligibility criteria
N/A
The influence of statins on reflex vasodilation
This study explores the effect of statin therapy (e.g. Lipitor) on the impaired function that occurs in the small blood vessels in the skin of humans who have high serum cholesterol. To do this, we examine the dilation of blood vessels that depends upon nitric oxide (a signaling substance made by the body) and the relation between the skin's nerves and skin blood flow. There are 3 groups of participants:
o no statin, LDL <149
o statin* for ≥ 3 months, LDL <149
o no statin, LDL ≥149
* statin prescribed by personal physician to lower serum cholesterol
This study uses the minimally invasive microdialysis and microneurography techniques as well as whole body heating.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
Show full eligibility criteria
N/A
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
Show full eligibility criteria
NCT03387813
Central Mechanisms of Neurovascular Dysfunction in Human Depression
Our goal is to identify what leads to the increased risk of cardiovascular disease and stroke in adults with depression. This study may help identify treatments or preventative strategies that will work best to reduce the risk of cardiovascular disease, stroke, and death in these patients.
Subjects will be between 18 and 40 years. Three subject groups will be recruited:
1. Healthy control (HC) subjects will not have a family history of Major Depressive Disorder (MDD) or major psychiatric illness
2. MDD patients will have clinically significant depression (non-medicated)
3. Selective serotonin reuptake inhibitor (SSRI)-treated adults (MDD in remission; monotherapy) will have been treated for at least 8 weeks prior to study enrollment
A medical screening determines study eligibility. The screening includes a physical exam and medical history, height, weight, and waist circumference measurements, and recording the electrical activity of the heart (ECG). Screening also includes a blood draw for basic blood biochemistry, including a lipid profile and assessment of liver and kidney function. Subject-groups are matched for age and sex.
During the experiments, we assess nervous system activity and blood pressure continuously. The experiments include intravenous infusion of substances that alter dilation or constriction of blood vessels. These substances work by promoting or blocking certain steps in the signaling pathways that control blood flow. This technique allows us to compare differences between subject-groups in the mechanisms governing the nervous system input in the control of blood flow. This project includes blood draws and the recording of nerve activity in the leg.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
Show full eligibility criteria
N/A
The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared with a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease
This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for CVD (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).
We hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.
Valerie Sullivan at vks5014@psu.edu or 1-866-PSU-DIET
All
18 year(s) or older
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NCT03020758
Effects of cranberry juice on cardiovascular risk factors in a placebo-controlled crossover trial
The purpose of this study is to evaluate the effects of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. We hypothesize that the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure and arterial health, as well as LDL-C and HDL function.
Stacey Meily at sas117@psu.edu or 814-863-8622
All
18 year(s) or older
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NCT02556749
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
This study will evaluate and compare the health benefits of using functional electrical stimulation for lower extremity exercise with diet versus diet alone in adults with spinal cord injury.
Kristin Slavoski, MS at PMR_research@pennstatehealth.psu.edu or 717-531-0003 x283816
All
18 year(s) or older
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N/A
The effects of habitual physical activity on EDHF-mediated vasodilation in healthy aging
Cardiovascular disease remains the leading cause of death in the United States. Increased age is the leading risk factor for cardiovascular disease. Aging is associated with decreased vessel function. Nitric oxide, a substance produced by our bodies, is responsible for making our vessels increase their diameter and allow blood to flow. However, other substances may also cause our blood vessels to get larger. We are doing this research project to understand how physical activity affects these other substances.
Sean Shank at sqs6071@psu.edu or 814-863-8557
All
18 year(s) or older
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N/A
A Randomized, Double-blind, Placebo-controlled, Concentration guided, Exploratory Study of Mavacamten (MYK 461) in Patients with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection Fraction
The study will test the safety of a 16-week course of mavacamten in individuals with symptomatic non-obstructive hypertrophic cardiomyopathy as well as how well they do while on the medication.
All
18 year(s) or older
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NCT03442764
The postprandial effects of a high fat meal containing spices on endothelial function: a pilot study
We aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of a least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.
Kristina Petersen at kup63@psu.edu or 8148638622
Male
18 year(s) or older
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NCT03064958
A randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infraction
We are trying to find out if chelation therapy in the vein and oral vitamins and minerals by mouth lower the risk of new heart problems, including another heart attack, chest pains, or heart surgery to open blood vessels. The therapy, chelation, is a drug given by vein that that sticks to heavy metals, like lead and cadmium, and takes them out of the body in the urine. These metals may lead to heart disease. A prior study suggested benefit with chelation therapy when given to patients who have had a myocardial infarction and have diabetes.
Katie Loffredo at PSHVIResearchCoordinators@pennstatehealth.psu.edu or (717) 531-5825
All
18 year(s) or older
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NCT02733185
Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
This is a clinical study that will examine the effects of supplementation with freeze dried strawberry powder on multiple markers of cardiovascular disease risk.
Stacey Meily at sas117@psu.edu or 814-863-8622
All
18 year(s) or older
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NCT02557334
The effect of potatoes on markers of cardiometabolic health
The purpose of this study is to determine the effect of daily potato consumption on markers of cardiometabolic health. Participants will be asked to consume a potato based side dish and a grain based side dish each for 4 weeks.
Emily Johnston at exj22@psu.edu or 1-886-778 3438
All
18 year(s) or older
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NCT03495284
A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects with Acute Ischemic Stroke
The primary objective of the study is to assess the safety and tolerability of DS-1040b (intravenous [IV] infusion over 6 hours) in subjects with AIS within 4.5 to 12 hours after stroke symptom onset.
Deborah Hoffman at dhoffman1@pennstatehealth.psu.edu or 717 531 0003 x283063
All
18 year(s) or older
Show full eligibility criteria
NCT02586233