How to Enroll:
If you are interested in participating, please call 718-818-2707 or contact the Department of Clinical Research at [email protected]. We will provide answers to your questions and help you decide whether or not you are a good candidate for this study.
Study#1: Hypertension:
According to the World Health Organization, only about 1 in 5 adults (21%) with hypertension have it under control. Uncontrolled hypertension occurs when blood pressure readings remain above 140/90 mmHg despite lifestyle changes and being on antihypertensive medication. Over time, uncontrolled hypertension can cause serious damage to the heart by decreasing the flow of blood and oxygen. It is a major risk factor for heart attack, stroke, vascular disease and chronic kidney disease.
The Department of Clinical Research has an ongoing study named TLA-201. It is a clinical trial for adults aged 18 to 80 years who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure. The purpose of this trial is to evaluate the blood pressure lowering efficacy, safety, pharmacokinetics, and immunogenicity of Tonlamarsen, an investigational drug that is administered subcutaneously for adults with uncontrolled hypertension.
What to Expect:
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate and compensation may be available.
Who Should Enroll?
You may be able to participate in this study if you are an adult aged 18 to 80 years (inclusive) and:
- Have a history of uncontrolled hypertension
- Are receiving between 2 and 5 antihypertensive medications prescribed for hypertension (inclusive) without changes in antihypertensive regimen
- Agree to maintain this regimen throughout the Treatment Period.
There are other criteria that you must meet in order to participate in the TLA-201 Trial, which the study team can discuss with you.
Study #2: Heart Failure with Obesity:
Heart Failure with Obesity is a chronic condition in which the heart is unable to pump blood effectively to meet the body’s needs. Obesity is a common risk factor that not only increases the likelihood of developing heart failure but also worsens its progression. The combination of these two conditions is becoming more common and is associated with reduced quality of life, increased hospitalizations, and a higher risk of death. People with heart failure and obesity may experience symptoms such as shortness of breath, fatigue, and swelling. Currently, treatment options are limited, and there is an urgent need for therapies that specifically target the dual impact of obesity and heart failure.
The Department of Clinical Research is conducting a clinical study called MARITIME-HF. This is a clinical trial for adults 18 years of age and older who have been diagnosed with heart failure and have a body mass index (BMI) of 30 or greater. The purpose of the trial is to evaluate whether the investigational drug is a safe and effective treatment option for improving heart function and symptoms in people with obesity. The clinical trial will assess whether the investigational drug improves cardiovascular performance, reduces symptoms, enhances quality of life, and lowers the risk of hospitalizations. Participation in the study includes regular monitoring and support throughout the duration of the trial.
What to Expect:
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate and compensation may be available.
In this trial, the investigational drug will be compared to a placebo, which looks like the investigational drug but contains no active ingredients. Participants will receive treatment with a 1:1 chance to receive either the investigational drug or a placebo.
Who Should Enroll?
You may be able to participate in this clinical trial if you are 18 years of age or older and:
- Have been diagnosed with heart failure
- BMI > 30 kg/m2
There are other criteria that you must meet in order to participate in the MARITIME-HF Trial, which the study team will be glad to discuss with you.
Study #3: Heart Failure with Impaired Kidney Function (BalanceD-HF):
Heart failure is when the heart muscle becomes too weak or stiff to pump blood effectively through the whole body. Heart failure is a long-lasting condition that can cause symptoms such as shortness of breath, tiredness, feeling lightheaded or dizzy, and swelling of certain tissues such as the feet and ankles. With serious cases of heart failure, there is an increased risk of other heart problems and death. Additionally, people with heart failure often have reduced kidney function, which further increases the risk of heart problems and death.
The kidneys and the heart work together to keep you healthy, and when one stops working properly, it can cause problems for the other. Some medications and treatments commonly used for heart failure can cause damage to the kidneys over time, and having impaired kidney function can make it unsafe to take certain common heart failure treatments. Because these two organs are so closely linked, we must find new treatments that are effective for managing heart failure in combination with impaired kidney function.
The Department of Clinical Research has an ongoing study named BalanceD-HF. It is a clinical trial for adults 18 years of age or older with heart failure as well as impaired kidney function related to their heart failure. The purpose of the trial is to evaluate two treatments working together: balcinrenone and dapagliflozin. Dapagliflozin is a drug that is known to protect the heart and kidneys, and it is already used to treat heart failure and kidney disease. Balcinrenone is an experimental drug that works similarly to other drugs that are already used for heart failure treatment, but balcinrenone may protect the heart and kidneys without the same side effects that those drugs cause. This clinical trial will look to see how safe and effective the combination of these two drugs is as a treatment and to see whether these two drugs in combination are better at protecting the heart and kidneys than dapagliflozin alone.
What to Expect
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate, and if applicable, you may be reimbursed for reasonable expenses incurred due to your participation such as the cost of parking. Additionally, if you qualify, you will be compensated for the completion of each study visit.
In this trial, there will be three different treatment groups. All three treatment groups will receive 10mg of dapagliflozin, 2 of the groups will receive balcinrenone at different doses, and the third group will receive a placebo (which looks like the investigational drug but contains no active ingredients) instead of balcinrenone. Participants will be assigned by random chance to one of the 3 treatment groups, and neither they nor the study team will know which group they belong to. Everyone in the study will get treatment with at least dapagliflozin, and throughout the study, participants will be able to keep taking their regular medications for heart failure and impaired kidney function.
Who Should Enroll?
You may be able to participate in this clinical trial if you are 18 years of age or older and:
- You have been diagnosed with heart failure and had a recent (within the last 6 months) worsening of your symptoms that required hospitalization or an urgent out-patient visit
- You have decreased/poor kidney function that is related to your heart failure
Study #4: Cardiovascular Disease – Acute Coronary Syndrome (ACS)
Cardiovascular disease is a group of diseases affecting your heart and blood vessels. Almost half of all adults in the U.S. have at least one form of heart disease. These are the leading cause of death in the U.S. and worldwide. Acute Coronary Syndrome (ACS) is a group of conditions that suddenly stop or severely reduce blood flowing to the heart muscles. When blood cannot flow to the heart muscle, the heart muscle can become damaged. Myocardial infraction and unstable angina are both ACS.
In simple words, Myocardial infarction is a heart attack, a medical emergency, and it happens when a part of the heart muscle does not get enough blood. Unstable angina is a type of chest pain which happens when your heart is not getting enough oxygen-rich blood. The more time that passes without treatment to restore blood flow, the greater the damage to the heart muscle.
Several health conditions, your lifestyle, and your age and family history/genetics can increase your risk of heart disease and heart attack. These are called risk factors. Some risk factors cannot be controlled, such as your age or family history/genetics. But you can take steps to lower your risk by changing the factors you can control.
The Department of Clinical Research has an ongoing study that will provide eligible genetically defined population (AA genotype at variant rs1967309 in adenylate cyclase type 9 gene) with recent ACS patients with an easily administered FDA proved drug focused on helping reduce the future heart attack and stroke. Our study medicine increases your good cholesterol level, HDL in your blood.
What to Expect:
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate and compensation may be available.
Who Should Enroll?
This study focuses on a genetically defined population (AA genotype at variant rs1967309 in adenylate cyclase type 9 gene) with recent ACS. You may be able to participate in this clinical trial if you are 45 years of age or older and:
- Willing to provide informed consent prior to initiation of any study specific activities/procedures
- Aqe >= 45years
- AA genotype at variant rs1967309 in adenylate cyclase type 9 gene which will be determined at a designated investigational testing site.
- Myocardial infraction (within last 3 months)
- Hospitalization for ACS
There are other criteria that you must meet in order to participate in the Dal-GenE-2 Trial, which the study team can discuss with you.
In this trial, an investigational drug will be compared to a placebo, which looks like the investigational drug tablet but contains no active ingredients. Participants will be assigned by chance to receive either 1 of the 2 doses of the investigational drug or placebo.
Study #5: Atherosclerotic Cardiovascular Disease (ASCVD)
Atherosclerotic cardiovascular disease (ASCVD) is a condition that occurs when fat, cholesterol, and other substances build up in the arteries (also called plaques), restricting healthy blood flow to organs and other parts of the body. When ASCVD blocks blood flow to the heart or brain, it can lead to a heart attack or stroke. ASCVD remains a leading cause of morbidity and the leading cause of death worldwide. Atherosclerosis often has no symptoms until a plaque ruptures or the buildup is severe enough to block blood flow. A healthy diet and exercise can help. Treatments include medications and arterial revascularization (surgical procedures to open blocked arteries). Patients undergoing these arterial revascularizations for symptomatic ASCVD are at high risk for subsequent cardiovascular and limb events such as heart attack, coronary heart disease death, and limb ischemia. Several drugs that lower bad cholesterol level, Low density lipoprotein cholesterol (LDL-C) have been shown to reduce ischemic risk in patients with ASCVD including Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD).
The Department of Clinical Research has an ongoing study to evaluate the hypothesis that acute LDL-C lowering with our study drug initiated early after successful revascularization procedure on top of usual lipid management reduces the risk of future cardiovascular and limb artery blockage.
What to Expect:
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate and compensation may be available.
Who Should Enroll?
This study focuses on patients with symptomatic ASCVD who recently underwent or have a planned revascularization procedure. You may be able to participate in this clinical trial if you meet the eligibility criteria:
- Willing to provide informed consent prior to initiation of any study specific activities/procedures
- Aqe >= 18 years
- Within 14 days of a successful qualifying arterial revascularization procedure for symptomatic CAD or PAD.
In this trial, an investigational drug will be compared to a placebo, which looks like the investigational drug pre-filled injection (subcutaneous) but contains no active ingredients. Participants will be assigned by chance to receive either 1 of the 2 doses of the investigational drug or placebo.
Study #6: Type 2 Diabetes Mellitus
Type 2 diabetes raises the level of glucose in your blood. Over time, your high glucose levels can cause damage to your blood vessels. Your doctor is able to test your blood glucose levels by taking an HbA1c blood test, which measures your glucose levels over the past few months. Controlling your glucose levels can help keep your blood vessels healthy and lower your risk for health conditions like heart disease or stroke.
The Department of Clinical Research has an ongoing study named GZFD Study. It is a clinical trial for adult patients with type 2 diabetes who failed to reach their HbA1c goals with the use of Ozempic or Mounjaro. The purpose of this trial is to test the investigational medicine’s ability to help lower your HbA1c levels.
What to Expect?
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. If you agree to participate, you will begin the screening period. During this time, the medical staff will perform tests to see if you qualify for the study. If you do qualify for the study, you will start taking the study medicine for the next 24 weeks. You will be required to make monthly visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate and compensation may be available.
Who Should Enroll:
You may be able to participate in this clinical trial if you:
– Are between 18 and 75 years of age
– Have type 2 diabetes for at least 6 months
– Have a BMI of 27 or higher
– Have been taking Ozempic or Mounjaro at the same dose for at least 3 months
Study #7: Adjustment Disorder:
Adjustment disorder (AjD) is a stress-related condition characterized by an excessive emotional and/or behavioral response to a significant life change or stressor that can severely impair daily functioning. AjD due to cancer or other medical illness such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson’s disease (PD), or idiopathic pulmonary fibrosis (IPF) can be distressing for both patients and caregivers on top of significantly affecting a patient’s quality of life and functioning. Today, there are no pharmacotherapies or combined pharmacological-psychosocial interventions approved to treat AjD due to medical illness.
The Department of Clinical Research has an ongoing study looking into the investigational psychotropic medication, RE104 for injection. The purpose of the study is to evaluate if RE104 for injection is effective in treating depressive symptoms in participants with adjustment disorder. A rapid-acting psychotropic medication with favorable safety would allow patients to better employ available coping strategies and prevent progression into a severe mental disorder.
What to Expect:
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. Once you begin the study, you will be required to make regular visits to the hospital, where the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule. There is no cost to participate, and compensation may be available.
In this trial, the patient will receive a single injection of RE104 (30 mg or 1.5 mg) under clinical supervision, after which they will be closely monitored for a period of 8 hours to assess for any immediate adverse reactions or side effects. During this time, vital signs and overall condition will be regularly evaluated. Following the initial dosing day, the patient will enter a 42-day follow-up period that involves ongoing assessments that include regular check-ins, clinical evaluations and any necessary diagnostic testing to ensure the patient remains in a stable and healthy condition.
Who Should Enroll?
You may be able to participate in this clinical trial if you are 18 years of age or older and:
- Have one of the following medical illnesses: Cancer, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson’s disease (PD), or idiopathic pulmonary fibrosis (IPF)
- Have ≥4-week history of AjD that was instigated by one of the medical illnesses listed above
There are other criteria that you must meet in order to participate in the trial, which the study team can discuss with you.
Study #8: Major Depressive Disorder (MDD):
Major Depressive Disorder (MDD) is a mental health condition characterized by sustained feelings of sadness, hopelessness, and a loss of interest or pleasure in daily activities, significantly impairing a person’s ability to function in everyday life. Despite the currently available treatments, a significant unmet need remains, as many patients with MDD have an inadequate response to first-line pharmacotherapies.
The Department of Clinical Research has an ongoing study named KOASTAL-3. It is a clinical trial for patients with MDD. The purpose of this trial is to test the investigational medicine, NMRA-335140, efficiency relative to placebo on symptoms of depression in adult participants with MDD. Given the urgent need for well-tolerated pharmacotherapies that effectively treat the core of MDD symptoms, findings have shown support for NMRA-335140 as a potential single drug treatment for patients with symptoms of depression.
What to Expect?
All participants are monitored closely to ensure their safety. Before participating, you will have a chance to sit down with the medical staff and discuss the benefits and possible risks, as well as study procedures. There will also be time to ask any questions you might have. If you agree to participate, you will begin the screening period. During this time, you will complete various assessments to see if you are suitable for the study. There is no cost to participate and compensation may be available.
One of these assessments would be questionnaires from the site staff. You will also have two separate phone interviews performed by independent clinicians to better understand the extent of your psychiatric symptoms. When taking antidepressant medications, you might experience eye related side effects. In order to assess general ocular disorders, you will have an eye assessment where the optometrist will dilate your pupils.
Once you have passed the all the interviews and assessments, you will begin the study treatment period. For the next six weeks, you will be taking the investigational drug. During this time you will be coming into the hospital every 7 to 14 days depending on the visit. In these visits, the medical staff will perform tests and assessments to see how your body is responding to the medication. The visiting times are flexible to accommodate your schedule.
You will be given the option to enter the long term version of this study. This just means that you will be taking the study medicine for longer than 6 weeks. If you choose not to do this, the study will take a total 16 weeks. If you choose to continue on and be a part of the extension study, you would be on the study medicine for an additional 52 weeks, or a year. This will mean your total participation in the study will be 60 weeks long.
Who Should Enroll:
You may be able to participate in this clinical trial if you:
– Are between 18 to 65 years of age
– Have a diagnosis of MDD
– Are willing and able to give informed consent
