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Ongoing Clinical Studies and Trials

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Cardiovascular Disease

Cardiovascular disease is the leading cause of death and disability, accounting for approximately 31% of all deaths and 46% of deaths from noncommunicable diseases worldwide (World Health Organization, 2014). Of deaths related to cardiovascular disease, approximately 80% are from myocardial infarction or stroke (World Health Organization, 2014).

Myocardial infarction, in simple words, a heart attack, is a medical emergency. It happens when a part of the heart muscle does not get enough 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, age and family history can increase your risk for heart disease and heart attack. These are called risk factors. About half of all Americans have at least one of the three key risk factors for heart disease: high blood pressure, high blood cholesterol, and/or smoking. Some risk factors cannot be controlled, such as your age or family history. But you can take steps to lower your risk by changing the factors you can control.

At Richmond University Medical Center, the Department of Clinical Research has an ongoing study that will provide eligible heart attack patients with an easily administered FDA proved drug focused on helping reduce the future heart attack and stroke. Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), is a modifiable independent cardiovascular risk factor. Our study medicine reduces your bad cholesterol level, LDL in your blood.

What to Expect:

Clinical research studies help advance science, give patients access to new medicine, and provide hope for future patients. 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 who have been hospitalized for a heart attack. Older adults and individuals with significant comorbidities, such as cardiovascular diseases, diabetes, hypertension, and obesity are considered a high-risk population and if they have recent hospitalization due to heart attack are welcome to participate in this study. In order to qualify, you must meet the following criteria:

  • Willing to provide informed consent prior to initiation of any study specific activities/procedures.
  • 18 years of age or older.
  • Have been recently hospitalized with heart attack being the primary reason.

How to Enroll:

If you are interested in participating, please call 718-818-2707 or contact the Department of Clinical Research at research@rumcsi.org. We will provide answers to your questions and help you decide whether or not you are a good candidate for this study.


COVID-19

COVID-19 has been at the center of various research studies. Due to it being highly contagious, it has caused great concern among medical professionals and the general public. Generally, COVID-19 causes fever and respiratory symptoms. However, other symptoms could include neurological, gastrointestinal, cardiac, and taste and smell abnormalities. The spectrum of this disease could range from asymptomatic infection to multi-organ failure. Currently, there are limited medications available to treat COVID-19. Those that are available, such as Remdesivir, dexamethasone, and IV antibody treatments, are authorized for hospitalized COVID-19 patients. As a result, it is clear that an easily administered outpatient medication for COVID-19 patients is a significant medical need.

At Richmond University Medical Center, the Department of Clinical Research has an ongoing study that will provide eligible COVID-19 patients with an easily administered study drug focused on helping prevent the worsening of COVID-19.

What to Expect:

Clinical research studies help advance science, give patients access to new medicine, and provide hope for future patients. 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 high-risk patients with mild to moderate COVID-19. Older adults and individuals with significant comorbidities, such as cardiorespiratory diseases, diabetes, hypertension, and obesity are considered a high-risk population and are welcome to participate in this study. In order to qualify, you must meet the following criteria:

  • Have a positive COVID-19 diagnosis within the last 5 days
  • Have one or more COVID-19 symptoms within the last 5 days
  • Considered to be at higher risk for progression to more severe COVID-19

How to Enroll:

If you are interested in participating, please call 718-818-2707 or contact the Department of Clinical Research at research@rumcsi.org. We will provide answers to your questions and help you decide whether or not you are a good candidate for this study.


Non Alcoholic Liver Disease

NASH (non-alcoholic steatohepatitis) is a progressive and chronic liver disease caused by an excess of fat and inflammation in the liver, and its prevalence is increasing. NASH is the liver manifestation of conditions that belong to the metabolic syndrome, including cardiovascular disease, type 2 diabetes, obesity and hypertension. Over time, NASH can lead to serious health problems such as fibrosis (scarring) of the liver and permanent liver damage that may require a liver transplant. Many people with NASH have no or few symptoms and remain undiagnosed. Today, there is no approved drug to stop or reverse NASH with liver fibrosis.

At Richmond University Medical Center, the Department of Clinical Research has as ongoing study named, NATiV3. It is a clinical trial for adults 18 years of age and older with NASH and liver fibrosis stage 2 or 3. The purpose of the trial is to evaluate if an oral investigational drug (lanifibranor) is a safe and effective potential treatment option for NASH. The clinical trial will evaluate if the investigational drug reduces the scars on your liver (fibrosis), resolves NASH, delays or stops damage to liver function and improves the way you feel throughout the trial.

What to Expect:

Clinical research studies help advance science, give patients access to new medicine, and provide hope for future patients. 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 2 different doses of the investigational drug will be compared to 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.

Because there are no approved drugs available for NASH with fibrosis, participants assigned to receive the placebo will not be at an additional risk. All participants will receive standard-of-care treatment and will be closely monitored by the study team.

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 or are at risk for NASH with fibrosis

• Do not have any other chronic liver disease

There are other criteria that you must meet in order to participate in the NATiV3 Trial, which the study team can discuss with you.

How to Enroll:

If you are interested in participating, please call 718-818-2707 or contact the Department of Clinical Research at research@rumcsi.org. We will provide answers to your questions and help you decide whether or not you are a good candidate for this study.


Severe Heart Failure Studies

There is no guaranteed cure for heart failure, but these are studies designed to reduce symptoms and prolong life:

CONNECT-HF is a three arm study of regular hospital treatment through referrals to community services such as the visiting nurse organization compared to a team of healthcare providers who virtually live with patients to oversee diet, activity, medication and more. The third arm of the study is the provision of smartphones with an app that reminds patients of what they need to do through self-care. Richmond University Medical Center is studying this smart phone arm; heart failure patients with smart phones may be eligible for enrollment. Heart failure patients readmitted within 30 days cause the hospital to be financially penalized and these studies are designed to determine which of the three provide the longest remission.

HEART- FID is a study of severe heart failure associated with anemia to determine whether a new preparation of intravenous iron can reverse the anemia and relieve the heart failure. Curing the anemia allows the blood to carry more oxygen to the failing heart muscle.