| Trial ID: | L5038 |
| Source ID: | NCT03640221
|
| Associated Drug: |
Ertugliflozin
|
| Title: |
Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.
|
| Acronym: |
Ertugliflozin
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Ertugliflozin|DRUG: Hydrochlorothiazide 12.5mg|DEVICE: Microneurography|OTHER: SKNA recordings|OTHER: Static Handgrip|OTHER: Post-handgrip forearm vascular occlusion|OTHER: Testing of the Arterial Baroreflex Function
|
| Outcome Measures: |
Primary: Muscle sympathetic nerve activity (bursts/minute), The primary outcome is the change from baseline in muscle sympathetic nerve activity after 3 months of daily treatment with either Ertugliflozin or hydrochlorothiazide. Muscle sympathetic nerve activity will be measured with microelectrodes inserted into the peroneal nerve (microneurography)., 3 months | Secondary: Outcome 2 is the increase in muscle sympathetic nerve activity in bursts/minute induced by static handgrip., Muscle sympathetic nerve activity will be measured at rest and after 2 minutes of static (isometric) handgrip at 33% maximum voluntary contraction. This exercised-induced response will be measured at baseline and after 3 months of Ertugliflozin or HCTZ., 3 months|Increase in muscle sympathetic nerve activity induced by post-hand grip forearm vascular occlusion, Muscle sympathetic nerve activity will be measured at rest and after 2 minutes of by post-handgrip forearm vascular occlusion. After 2 minutes of static handgrip at 33% maximum, a pneumatic cuff will be inflated on the upper exercised arm for 2 minutes. This response will be measured at baseline and after 3 months of Ertugliflozin or HCTZ., 3 months|Change in chest wall skin sympathetic nerve activity in bursts per minute., Chest wall skin sympathetic nerve activity, a non-invasive measure of cardiac sympathetic nerve activity, will be measured from standard surface ECG leads using appropriate filtering and amplification., 3 months|Arterial baroreflex gain., Baroreflex gain will be measured as the reflex increase in muscle sympathetic nerve activity in bursts/minutes per mm Hg peak decrease in mean arterial pressure induced by Valsalva strain (Phase III) and the reflex decrease in muscle sympathetic nerve activity per mm Hg during the peak overshoot in mean arterial pressure upon release of the Valsalva maneuver (Phase IV)., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Cedars-Sinai Medical Center | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-09-01
|
| Completion Date: |
2020-08-31
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-14
|
| Locations: |
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03640221
|
