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.

Seeking Patients with Heart Failure

The purpose of this research study is to examine whether a new medication called dapagliflozin will work and be safe for the treatment of heart failure in addition to the standard therapy used for treatment of heart failure.

Brigham and Women's Hospital Heart Failure
12 visits over 33 months
Estimated Time Commitment
Any Sex/Gender, 40-years or older
May Be Eligible
Payment up to $600
May Be Offered
Survey, Blood draw, Medication, Office visit
May Be Required
 
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This project is not recruiting.

Who can participate

• Patients who ages 40 and over
• Patients with a diagnosis of heart failure
• Patients with a LV Ejection Fraction > 40%
• Additional criteria based on lab tests and imaging

Who cannot participate

• Patients currently taking or who do not tolerate one of the following medications: dapagliflozin, canagliflozin, empagliflozin.
• Patients with type 1 diabetes mellitus.
• Female participants must not be pregnant or breastfeeding.
• Additional medical history and laboratory data to be reviewed by the study doctor.

What you may be asked to do

At study visits, we may:
• Ask you questions about yourself
• Ask about your medical history
• Review your medication list
• Perform a physical exam, including blood pressure, pulse, body weight, height
• Record an electrocardiogram (ECG – an electrical recording of your heart rate and rhythm)
• Draw blood from you for testing. If you are a woman of child-bearing potential, this will include a urine sample to test for pregnancy. The maximum volume of blood that will be collected during particular study visits is 4 mL or about 1 teaspoon.
• Asked to report on your overall health, quality of life, and heart failure symptoms


Based on your disease and medical history, as well as laboratory results from blood samples taken at visit 1, the study doctor will let you know if the study is suitable for your continued participation. If you are eligible, you will have to come to about 8 to 12 visits over the next 15–33 months, depending on when you enter the study. The 2nd study visit will be within 21 days of the first visit and the 3rd visit will be 30 days after 2nd visit. Visit 4 will be 4 months after the 2nd visit. The next visits will take place every 4 months thereafter until the end of the study when you will be asked to return for a last visit.


Project activities may include:

  • Survey
  • Blood draw
  • Medication
  • Office visit

Estimated Time Commitment

12 visits over 33 months

What You May Get

Participants will receive up to $50 for each completed study visit.

Location

Hale Building for Transformative Medicine (Clinical Trials Hub, 3rd Floor)
60 Fenwood Road, Boston, MA 02115

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT03619213


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
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