Do You Have High Blood Pressure? Is It Difficult To Control? You May Be Eligible for An Investigational Medical Procedure (New York, NY)
Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: The Mount Sinai Hospital, New York, New York
Location: 1 Gustave Levy Pl., New York, NY
Lead Doctor: George Dangas, MD
Institutional Review Board: Reviewed and approved by the Western Institutional Review Board
High blood pressure is a very common condition that puts many people at risk for developing heart disease or stroke. It also puts a lot of stress on the kidneys. When the kidneys are under stress, there is increased activity along the nervous system between the brain and kidneys. This activity can lead to even higher blood pressure.
There is evidence that blood pressure may be reduced if certain nerve activity around the kidney is disrupted. This can be done during a short procedure (30 to 75 minutes) using an investigational medical device. The purpose of this study is to provide additional information about an investigational medical device used in this procedure.
This study seeks people with high blood pressure to participate. Participants must be willing to undergo a short procedure (30 to 75 minutes) with the goal of disrupting nerve activity around the kidney. After the procedure, participants will be evaluated for any change in their blood pressure.
Potential Benefits to Participation
- You may see an improvement in your blood pressure
- You may undergo the procedure and if you do it will be performed at no charge.
- Data obtained from this study may contribute to advancing medical research in the field of hypertension
- You will be reimbursed $50 per site visit to cover your travel and/or parking expenses.
- There are risks associated with any medical procedure. Please talk with a study doctor to understand which risks may pertain to you and your current medical condition.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your records relating to this study and any other information received will be kept strictly confidential.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Men and women aged 20 – 80 who have high blood pressure.
- Willing to undergo a short procedure (30 to 75 minutes) that uses an investigational medical device.
- Willing to attend 8 to 12 on-site visits at the research site over the initial 12 month period and attend one follow up visit per year for the following 2 years.