Trial Outcomes & Findings for Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension (NCT NCT01519635)
NCT ID: NCT01519635
Last Updated: 2020-03-17
Results Overview
Changes in R2\* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
week 0 vs week 8
Results posted on
2020-03-17
Participant Flow
47 patients were screened in a single centre (service of Nephrology, CHUV, Lausanne)
24 patients were enrolled but 4 were excluded because of the lack of adequate venous access or for other reasons.
Participant milestones
| Measure |
Aliskiren
Aliskiren: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
11 patients were enrolled and completed the study
|
Hydrochlorothiazide
Hydrochlorothiazide: Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
Finally 9 patients were enrolled and completed the study
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Aliskiren
Aliskiren: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
11 patients were enrolled and completed the study
|
Hydrochlorothiazide
Hydrochlorothiazide: Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
Finally 9 patients were enrolled and completed the study
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
No possibility to put a catheter
|
1
|
2
|
Baseline Characteristics
Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren
n=11 Participants
Patients with essential hypertension stage 1 and 2 .
|
HCTZ
n=9 Participants
Patients with essential hypertension stage 1 and 2
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 8.6 • n=39 Participants
|
49.7 years
STANDARD_DEVIATION 15 • n=41 Participants
|
52.7 years
STANDARD_DEVIATION 12 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
Switzerland
|
11 participants
n=39 Participants
|
9 participants
n=41 Participants
|
20 participants
n=35 Participants
|
|
blood pressure
|
150 mmHg
STANDARD_DEVIATION 10.7 • n=39 Participants
|
141 mmHg
STANDARD_DEVIATION 12.9 • n=41 Participants
|
146 mmHg
STANDARD_DEVIATION 11.5 • n=35 Participants
|
PRIMARY outcome
Timeframe: week 0 vs week 8Changes in R2\* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney
Outcome measures
| Measure |
Aliskiren
n=11 Participants
Aliskiren: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
|
Hydrochlorothiazide
n=9 Participants
Hydrochlorothiazide: Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
|
|---|---|---|
|
Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide
Cortex week 0
|
20.5 1/sec
Standard Error 1
|
19.5 1/sec
Standard Error 1
|
|
Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide
Cortex week 8
|
19.5 1/sec
Standard Error 1
|
20.5 1/sec
Standard Error 1
|
Adverse Events
Aliskiren
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrochlorothiazide
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
Prof Michel Burnier
Service of Nephrology, Centre Hospitalier Universitaire Vaudois, Lausanne
Phone: +41 21 314 11 54
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place