Penn's Renal-Electrolyte and Hypertension Division

View the studies being performed to help treat hypertension in patients whose blood pressure is not controlled.

SPYRAL HTN-OFF MED

  • Name of PI, Sub I and Coordinator:
    • PI - Debbie Cohen, MD
    • SubI - Yonghong Huan, MD
    • SubI - Matt Denker, MD
    • Robin Neubauer, RN
  • Contact:
    Robin Neubauer, RN
    robin.neubauer@uphs.upenn.edu
    215-615-0773
  • Purpose of Study/Patient Population:
    The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients who are currently not taking medications for high blood pressure.
  • Inclusion:
    SBP > 150 mmHg and <180 mmHg and DBP >90 mmHg measured at Screening Visit 2, 24-hour ABPM average SBP >140 mmHg and <170 mmHg measured at Screening Visit 2, Individual is willing to discontinue current antihypertensive medications at Screening Visit 1 through the three month post-procedure visit.
  • Exclusion:
    eGFR of <45 mL/min/1.73m , using the MDRD calculation, Individual has documented type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus with hgba1c greater than 8.0%, has known pheochromocytoma, Cushing's Disease (adrenal insufficiency), coarctation of the aorta, untreated hyper- or hypothyroidism, or primary hyperparathyroidism, experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.

SPYRAL HTN-ON MED

  • Name of PI, Sub I and Coordinator:
    • PI - Debbie Cohen, MD
    • SubI - Yonghong Huan, MD
    • SubI - Matt Denker, MD; Robin Neubauer, RN
  • Contact:
  • Purpose of Study/Patient Population:
    The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with three blood pressure medications.
  • Inclusion:
    SBP > 150 mmHg and <180 mmHg and DBP >90 mmHg measured at Screening Visit 2, 24-hour ABPM average SBP >140 mmHg and <170 mmHg measured at Screening Visit 2, when receiving a medication regimen of three antihypertensive medications on at least 50% of the maximum manufacturer's dosage; the three anti-hypertensive medications must include a thiazide-type diuretic, a dihydropyridine calciumthiazidetype diuretic per standard of care.
  • Exclusion:
    eGFR of <45 mL/min/1.73m , using the MDRD calculation, Individual has documented type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus with hgba1c greater than 8.0%, has known pheochromocytoma, Cushing's Disease (adrenal insuffiency), coarctation of the aorta, untreated hyper- or hypothyroidism, or primary hyperparathyroidism, experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
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