Trial Outcomes & Findings for The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension (NCT NCT01996449)
NCT ID: NCT01996449
Last Updated: 2022-03-18
Results Overview
measurement of sympathetic nerve activity by microneurography (intraneural microelectrodes)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
8 weeks post treatment initiation
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Amlodipine Then Eplerenone
The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks.
|
Eplerenone Then Amlodipine
The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks.
|
|---|---|---|
|
Period 1: First Drug
STARTED
|
6
|
8
|
|
Period 1: First Drug
COMPLETED
|
6
|
8
|
|
Period 1: First Drug
NOT COMPLETED
|
0
|
0
|
|
Period 2: Second Drug
STARTED
|
6
|
8
|
|
Period 2: Second Drug
COMPLETED
|
6
|
8
|
|
Period 2: Second Drug
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension
Baseline characteristics by cohort
| Measure |
Amlodipine Then Eplerenone
n=6 Participants
The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks.
|
Eplerenone Then Amlodipine
n=8 Participants
The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 9 • n=99 Participants
|
50 years
STANDARD_DEVIATION 8 • n=107 Participants
|
51 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post treatment initiationmeasurement of sympathetic nerve activity by microneurography (intraneural microelectrodes)
Outcome measures
| Measure |
Amlodipine
n=14 Participants
Analysis independent of sequence. Amlodipine dosage (2.5 -10mg once daily) was titrated every 2 weeks to target BP of \< 140/90 mmHg
|
Eplerenone
n=14 Participants
Analysis independent of sequence. Eplerenone dosage (50-200 mg once daily) was titrated every 2 weeks to target BP of \< 140/90 mmHg.
|
|---|---|---|
|
Muscle Sympathetic Nerve Activity at Rest
|
41 bursts/minute
Standard Deviation 11.7
|
43.8 bursts/minute
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 8 weeks post treatment initiationmeasurement of sympathetic nerve activity by microneurography (intraneural microelectrodes) during arm cycling exercise
Outcome measures
| Measure |
Amlodipine
n=14 Participants
Analysis independent of sequence. Amlodipine dosage (2.5 -10mg once daily) was titrated every 2 weeks to target BP of \< 140/90 mmHg
|
Eplerenone
n=14 Participants
Analysis independent of sequence. Eplerenone dosage (50-200 mg once daily) was titrated every 2 weeks to target BP of \< 140/90 mmHg.
|
|---|---|---|
|
Muscle Sympathetic Nerve Activity During Exercise
|
47 bursts/minute
Standard Deviation 16
|
51 bursts/minute
Standard Deviation 18
|
Adverse Events
Amlodipine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eplerenone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place