The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be…
We are doing this study to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This is an FDA approved device. Involvement in the study is expected to last approximately 60 months. Patients will be asked to collect blood…
Race-Based Stress Reduction and Resilience Program for African-American Women. Join this important research study to examine the effectiveness of an eight-week stress reduction program for older African-American women. To learn more contact 347-978-2871 or son_RiSEstudy@cumc.columbia.edu. Study Requirements: African-American female between 50-75 years old,…
The measurement of blood pressure used to determine if a person has high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, blood pressure levels are different when measured in a provider's office versus during normal daily activities outside of…
We are working with researchers at Columbia University to test whether text messaging can be used effectively to help people with hypertension to control their blood pressure. If you are between the ages of 18 and 85 years and have a cell phone, you may be eligible to participate in this study. The study would involve a telephone call that would last about…
This purpose of this study is to understand the interaction between two different medications, tacrolimus and Paxlovid (nirmatrelvir/ritonavir), in patients who have had a kidney transplant and are being treated by their doctor for COVID-19 infection. Tacrolimus is an oral medication that is used standardly in kidney transplant recipients to prevent…
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
This is a 60-month adaptive to evaluate three siplizumab-based treatment regimens in kidney transplant recipients. The purpose of this research study is to see if the anti-rejection medications that patients normally take after transplant can be reduced or stopped completely by using several medications including the investigational drug siplizumab in the…
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and hepatitis C can be cured. The…
The purpose of this study is to determine if an investigational drug called tegoprubart (also known as AT1501) is safe and effective in preventing rejection in patients who are undergoing a kidney transplant for the first time. Participants will be randomly assigned to tegoprubart or standard treatment with tacrolimusat the time of transplant. If you have…
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will…
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
We are conducting a research study in adults to test whether blood pressure (BP) measured in a clinic setting without a technician present is comparable to blood pressure levels while awake outside of the clinic on an Ambulatory Blood Pressure Monitoring (ABPM) device. We will also test whether asleep blood pressure can be accurately determined using a home…
We are currently looking for men and non-pregnant women aged 40 years and above to participate in an at-home study on sleep and activity patterns in relation to blood pressure and blood glucose. Participants should not have critical/severe illness and should not be on dialysis or have a pacemaker or other implanted medical device. You must be willing to…
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed todemonstrate the effectiveness (how well it works) and safety of the Paradise Renal Denervation System in hypertensive subjects (subjects with high blood pressure).
Kidney transplant patients are at a higher risk for bone fractures compared to the general population. We are doing a clinical trial to examine the effects of 12-months of treatment with denosumab, a monoclonal antibody against RANKL, on bone density and strength as determined by bone imaging and by non-invasive measures of bone activity from blood and…
The study has been designed to demonstrate the efficacy and safety of the Paradise Renal Denervation System when treating patients with high blood pressure known as hypertension. When blood pressure is persistently elevated and pushes against the walls of the artery over a long period of time it is known to cause Hypertension. The Paradise Renal Denervation…
The purpose of this project is to collect more data about the safety and effectiveness of renal denervation (disabling of kidney nerves) for the treatment of uncontrolled hypertension. For therenal denervation procedure, the Vessix Renal Denervation System is used. The system consists of a catheter (a thin tube) and a radio frequency (RF) generator (power…
The purpose of this study is to find out more about how physical activity monitors can help assess patients with pulmonary hypertension. We hope to find a relationship between the data on physical activity monitors and the tests that routinely done in patients with pulmonary hypertension.
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
Subjects who undergo a kidney transplant require long term use of anti-rejection (immunosuppressive)drugs to prevent their body's immune system from attacking and damaging the newly transplanted kidney (rejection).The purpose of this study is to evaluate benefits and risks of two combinations(regimens) of immunosuppressive therapies: Thymoglobulin…
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
The purpose of this research study is to see if an investigational drug, BB3, is safe and effective forincreasing the amount of urine that a transplanted kidney will produce. An investigational drugis one that is not approved by the United States Food and Drug Administration (FDA). BB3 is agrowth factor-like drug, which means that it can affect cell…