Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Do you suffer from frequent chest pain?
This project is not recruiting.
Overview
What we are studying
This is a Phase II drug study to research a new investigational medication that may help with chest pain that may be related to microvascular angina (MVA). MVA occurs due to coronary microvascular dysfunction (CMD), a disease that affects the walls and inner lining of tiny coronary artery blood vessels that branch off from the larger coronary arteries. This new investigational drug is proposed to help dilate those small blood vessels, both improving chest pain and cardiac health in patients with MVA.
Why it is important
It is important to try and find a drug for patients suffering from microvascular angina because there are currently none on the market for this particular issue. As people living with MVA can tell you, it has a severe impact on quality of life and ability to perform physical tasks. The episodes of chest pain are often high in frequency, some people experiencing episodes of angina daily.
What we hope to accomplish
The hope is that this new investigational medication will improve patient health by decreasing symptoms as well as improving blood flow to the heart, as measured by PET/CT. If this trial proves successful, the study drug can then move onto the next phase and be closer to development and possibly available to the public.
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Principal Investigator
Who can participate
Patients must be 18-95 years old and experience episodes of chest pain at least once every two weeks. If they have not been diagnosed with microvascular disease, they must have had a coronary angiogram or coronary computed tomography angiography (CCTA) within the last two years that has shown non-obstructive coronary artery disease. If patients have been diagnosed with microvascular disease but have no cardiac imaging in the last two years, we will perform a CCTA as part of the study.
Who cannot participate
Patients with:
What you may be asked to do
If you choose to participate, and meet eligibility for this study, you will be asked to take study medication (SAR407899 or placebo) in a tablet form twice a day. We will ask you to come in once a week for blood work, urinalysis, and a complete physical exam including vital signs and ECG. You will also complete some questionnaires. We will also ask you to undergo two cardiac PET/CT imaging studies, one at the beginning of the study and one at the end. As a bonus, these will be available to your doctors. It will take you at least 6 weeks to complete this research study, but no longer 9 weeks. During this time, we will ask you to make up to 7 study visits to BWH and we will call you on the phone two or more times between study visits to see how you are doing.
Project activities may include:
- Injection or IV
- Blood draw
- Personal health tracking
- Survey
- Medication
- PET scan
- CT scan
Estimated Time Commitment
7 visits over 11 weeks
What You May Get
$108.00 per visit up to $756.00 Meal paid for at each visit Parking paid for at each visit
Location
Shapiro Cardiovascular Imaging
70 Francis Street L2 Boston, MA 02115
Travel
- Parking reimbursed
Travel and Parking Details
Please park valet and/or in a BWH parking garage and the study will pay for your parking.
Additional Information
Study Phase
Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.
Funding Source
- Industry