Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/11/2015 |
| Start Date: | August 2014 |
| End Date: | August 2018 |
| Contact: | Cheryl L Laffer, MD, PhD |
| Email: | cheryl.l.laffer@vanderbilt.edu |
| Phone: | 615-936-3623 |
The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug
Administration to treat rheumatoid arthritis, may help blood pressure medications to work
better. This will be studied in people with high blood pressure that is not well controlled
on three or more blood pressure medications, the condition also known as resistant
hypertension. We expect to show that adding abatacept therapy to standardized treatment of
resistant hypertension will result in a greater decrease in blood pressure at 24 weeks
compared to treatment with placebo and conventional blood pressure treatment.
Administration to treat rheumatoid arthritis, may help blood pressure medications to work
better. This will be studied in people with high blood pressure that is not well controlled
on three or more blood pressure medications, the condition also known as resistant
hypertension. We expect to show that adding abatacept therapy to standardized treatment of
resistant hypertension will result in a greater decrease in blood pressure at 24 weeks
compared to treatment with placebo and conventional blood pressure treatment.
Inclusion Criteria:
- Men and women 18 to 65 years of age with hypertension, treated with three or more
anti-hypertensive drugs, one being a diuretic, and
- having a systolic blood pressure >150 mmHg in the clinic and daytime average >150
mmHg on ambulatory blood pressure monitoring
Exclusion Criteria:
- Medical history of secondary cause of hypertension, severe obesity (BMI >35), severe
psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell
cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
- Inability to return for abatacept treatment and follow-up for 24 weeks.
- Inability to understand or complete study-related assessments.
- Current abuse of drugs or alcohol.
- Receipt of any live vaccines within 3 months of the anticipated first dose of study
medication.
- Evidence of active or latent bacterial or viral infections at the time of potential
enrollment, including human immunodeficiency virus (HIV)
- Risk for tuberculosis
- Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin
< 8.5 g/dL, white blood cell count < 3000/mm3, platelets < 100,000/mm3, creatinine >
2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate
aminotransferase > 2 times the ULN.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
