Trial Outcomes & Findings for Mineralocorticoid Receptor (MR) Antagonist (Eplerenone) vs Amlodipine and STRIATIN (NCT NCT03683069)
NCT ID: NCT03683069
Last Updated: 2025-03-19
Results Overview
Subjects will be counseled regarding liberal salt dietary intake to ensure similar intakes in all subjects \[Na+ (200 mEq), potassium (K+, 100 mEq) and calcium (800 mg)\]. This or a greater level of Na+ intake was consumed by 60-70% of subjects before entering the International Hypertensive Pathotype (HyperPATH) protocol. After completion of this diet for 7 days, the subject will come to the Center for Clinical Investigation (CCI) Ambulatory Clinical Center between 7-8 morning (AM), fasting, and after remaining supine for 60-90 mins will have blood samples obtained for future analyses, and their BP measured using an automatic recording sphygmomanometer. Readings will be obtained every 2 mins for 20 mins with the highest and lowest values discarded and the rest averaged. From the morning of the 6th to the morning of the 7th day, a 24hr. urine will be collected for creatinine and Na+ as a check on balance and stored for future analyses. Procedure will be performed before randomization and
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Change in blood pressure between visit 2 (baseline), visit 3 (four weeks), visit 4 (8 weeks), visit 5 (12 weeks) of randomized drug therapy
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Epleronone Arm
The first dose was 50mg/day; the second dose was 100mg /day, and the third dose was 200 mg/day. Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
Starting Dose for Amlodipine 2.5 mg/day; Second Dose is 5.0 mg/day; the Third Dose was 10 mg/day. Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
Epleronone Arm
The first dose was 50mg/day; the second dose was 100mg /day, and the third dose was 200 mg/day. Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
Starting Dose for Amlodipine 2.5 mg/day; Second Dose is 5.0 mg/day; the Third Dose was 10 mg/day. Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
Overall Study
see limitations
|
12
|
13
|
Baseline Characteristics
Mineralocorticoid Receptor (MR) Antagonist (Eplerenone) vs Amlodipine and STRIATIN
Baseline characteristics by cohort
| Measure |
Epleronone Arm
n=33 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=32 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
55 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
body mass index
|
30.0 kg/m squared
STANDARD_DEVIATION 6.2 • n=5 Participants
|
31.5 kg/m squared
STANDARD_DEVIATION 3.8 • n=7 Participants
|
30.7 kg/m squared
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
systolic blood pressure
|
144.2 mm hg
STANDARD_DEVIATION 15 • n=5 Participants
|
148.5 mm hg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
146.4 mm hg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
diastolic blood pressure
|
86.0 mm hg
STANDARD_DEVIATION 7.7 • n=5 Participants
|
91.4 mm hg
STANDARD_DEVIATION 7.2 • n=7 Participants
|
88.5 mm hg
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Salt Sensitivity of Blood Pressure (SSBP) systolic
|
8.6 mm hg
STANDARD_DEVIATION 13.6 • n=5 Participants
|
11.1 mm hg
STANDARD_DEVIATION 10.9 • n=7 Participants
|
9.9 mm hg
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
SSBP diastolic
|
3.5 mm hg
STANDARD_DEVIATION 7.6 • n=5 Participants
|
4.5 mm hg
STANDARD_DEVIATION 7.5 • n=7 Participants
|
4.0 mm hg
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
HGBA1C
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.4 • n=5 Participants
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change in blood pressure between visit 2 (baseline), visit 3 (four weeks), visit 4 (8 weeks), visit 5 (12 weeks) of randomized drug therapyPopulation: baseline liberal salt diet
Subjects will be counseled regarding liberal salt dietary intake to ensure similar intakes in all subjects \[Na+ (200 mEq), potassium (K+, 100 mEq) and calcium (800 mg)\]. This or a greater level of Na+ intake was consumed by 60-70% of subjects before entering the International Hypertensive Pathotype (HyperPATH) protocol. After completion of this diet for 7 days, the subject will come to the Center for Clinical Investigation (CCI) Ambulatory Clinical Center between 7-8 morning (AM), fasting, and after remaining supine for 60-90 mins will have blood samples obtained for future analyses, and their BP measured using an automatic recording sphygmomanometer. Readings will be obtained every 2 mins for 20 mins with the highest and lowest values discarded and the rest averaged. From the morning of the 6th to the morning of the 7th day, a 24hr. urine will be collected for creatinine and Na+ as a check on balance and stored for future analyses. Procedure will be performed before randomization and
Outcome measures
| Measure |
Epleronone Arm
n=33 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=32 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 2 systolic bp
|
144.2 mm hg
Standard Deviation 15
|
148.5 mm hg
Standard Deviation 10.5
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 2 diastolic bp
|
86.0 mm hg
Standard Deviation 7.7
|
91.4 mm hg
Standard Deviation 7.2
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 3 systolic bp
|
137.1 mm hg
Standard Deviation 13.2
|
144.5 mm hg
Standard Deviation 12.1
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 3 diastolic bp
|
83.7 mm hg
Standard Deviation 8.1
|
90.8 mm hg
Standard Deviation 7.8
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 4 systolic bp
|
135.4 mm hg
Standard Deviation 13.9
|
140.7 mm hg
Standard Deviation 11.8
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 4 diastolic bp
|
82.8 mm hg
Standard Deviation 8.4
|
87.5 mm hg
Standard Deviation 7.5
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
visit 5 Systolic BP
|
134.3 mm hg
Standard Deviation 11.7
|
135.9 mm hg
Standard Deviation 12.1
|
|
Systolic /Diastolic Supine Morning Liberal Salt Automated Blood Pressure
Visit 5 diastolic bp
|
83.1 mm hg
Standard Deviation 7.6
|
85.9 mm hg
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: Change in blood pressure between eplerenone and amlodipine at visit 2 (baseline), visit 3 (four weeks), visit 4 (8 weeks), visit 5 (12 weeks) of randomized drug therapyFirst step: subjects will ingest a liberal salt intake \[Na+ (200 mEq/day)\] for 7 days. The subject will come to the study unit between 7-8 AM, fasting. After remaining supine for 60-90 mins, their BP will be measured using an automatic recording sphygmomanometer. Readings will be obtained every 2 mins for 20 mins with the highest and lowest values discarded and the rest averaged. From the morning of the 6th to the morning of the 7th day, a 24-hr. urine will be collected for creatinine and Na+ as a check on balance and stored for future analyses. Second step: subjects will then be fed a restricted salt diet (10 mEq Na+/day) for 7 days. On the morning of the 7th day, the subjects will come fasting to the study unit between 7-8 AM, and the studies performed as detailed above. The BP data from the two diet studies will allow us to calculate SSBP. The procedures will be performed before randomization and at the completion of 12 weeks of therapy.
Outcome measures
| Measure |
Epleronone Arm
n=33 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=32 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 2 systolic
|
144.2 mm hg
Standard Deviation 15
|
148.5 mm hg
Standard Deviation 10.5
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit2 diastolic
|
86.0 mm hg
Standard Deviation 7.7
|
91.4 mm hg
Standard Deviation 7.2
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
systolic visit 3
|
137.1 mm hg
Standard Deviation 13.2
|
144.5 mm hg
Standard Deviation 12.1
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 3 diastolic
|
83.7 mm hg
Standard Deviation 8.1
|
90.8 mm hg
Standard Deviation 7.8
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 4 systolic
|
135.4 mm hg
Standard Deviation 13.9
|
140.7 mm hg
Standard Deviation 11.8
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 4 diastolic
|
82.8 mm hg
Standard Deviation 8.4
|
87.5 mm hg
Standard Deviation 7.5
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 5 systolic
|
134.3 mm hg
Standard Deviation 11.7
|
135.9 mm hg
Standard Deviation 12.1
|
|
Systolic/Diastolic Blood Pressure Visit 2, 3, 4, 5 Eplerenone vs Amlodipine
visit 5 diastolic
|
83.1 mm hg
Standard Deviation 7.6
|
85.9 mm hg
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: total 24 hour, daytime and night Change in blood pressure between visit 2 (baseline) and visit 5 (12 weeks) of randomized drug therapyFor this measurement, we used a separate set of data - continuous monitoring of blood pressure. These blood pressure measurements are different than those reported in the Primary Outcomes section. The Secondary Outcomes are continuous 24-hour blood pressures, measured twice. The 24 hour assessment was divided into 3 sections: total 24-hour, daytime and night; Change in blood pressure between visit 2 (baseline) and visit 5 (12 weeks) of randomized drug therapy
Outcome measures
| Measure |
Epleronone Arm
n=33 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=31 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
24 hr bp
24 hr systolic
|
8.45 mm hg
Standard Deviation 11.89
|
9.9 mm hg
Standard Deviation 10.28
|
|
24 hr bp
24 hour diastolic
|
4.33 mm hg
Standard Deviation 7.88
|
5.41 mm hg
Standard Deviation 6.73
|
|
24 hr bp
awake systolic
|
7.69 mm hg
Standard Deviation 13.15
|
10.03 mm hg
Standard Deviation 12.31
|
|
24 hr bp
awake diastolic
|
4.09 mm hg
Standard Deviation 9.02
|
5.35 mm hg
Standard Deviation 7.67
|
|
24 hr bp
asleep systolic
|
8.72 mm hg
Standard Deviation 13.01
|
10.96 mm hg
Standard Deviation 9.94
|
|
24 hr bp
asleep diastolic
|
3.63 mm hg
Standard Deviation 10.12
|
6.16 mm hg
Standard Deviation 7.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Those who achieved goal blood pressure at weeks 0 (visit 2), 4 (Visit 3), 8 Visit 4), 12 (Visit 5), and Number that did not achieve goal BP at Visit 5 (week 12). of randomized drug therapyPopulation: all subjects
We analyzed our results using Kaplan-Meier Plot and Cox-Hazard ratios and used the number of subjects who achieved goal blood pressure (e.g., \<140/90 mmHg) at weeks 0 (visit 2), 4 (Visit 3), 8 Visit 4), 12 (Visit 5), and Number that did not achieve goal BP at Visit 5 (week 12). Those individuals at week 12 who did not achieve goal blood pressure were identified as a separate group and termed non-responders. Thus, the value at each time is the percent of subjects at that time who achieved goal blood pressure.
Outcome measures
| Measure |
Epleronone Arm
n=33 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=32 Participants
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
|---|---|---|
|
The Percent of Individuals Who Achieved Goal Blood Pressure (e.g., <140/90 mmHg) at Each Time
Visit 2 (week 0)
|
33 Participants
|
32 Participants
|
|
The Percent of Individuals Who Achieved Goal Blood Pressure (e.g., <140/90 mmHg) at Each Time
Visit 3 (week 4)
|
13 Participants
|
7 Participants
|
|
The Percent of Individuals Who Achieved Goal Blood Pressure (e.g., <140/90 mmHg) at Each Time
Visit 4 (week 8)
|
6 Participants
|
4 Participants
|
|
The Percent of Individuals Who Achieved Goal Blood Pressure (e.g., <140/90 mmHg) at Each Time
Visit 5 (week 12)
|
7 Participants
|
10 Participants
|
|
The Percent of Individuals Who Achieved Goal Blood Pressure (e.g., <140/90 mmHg) at Each Time
Number that did not achieve goal BP at Visit 5 (week 12)
|
7 Participants
|
11 Participants
|
Adverse Events
Epleronone Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amlodipine Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epleronone Arm
n=33 participants at risk
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
|
Amlodipine Arm
n=32 participants at risk
Eplerenone vs Amlodipine: We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
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|---|---|---|
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General disorders
swelling
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0.00%
0/33 • 120 days
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9.4%
3/32 • Number of events 3 • 120 days
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Additional Information
Gordon H. Williams, Professor of Medicine
Brigham and Women's Hospital
Phone: 617-223-1611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place