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Trial record 10 of 443 for:    Hydrochlorothiazide

Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT01519635
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Aliskiren
Drug: Hydrochlorothiazide
Enrollment 24
Recruitment Details 47 patients were screened in a single centre (service of Nephrology, CHUV, Lausanne)
Pre-assignment Details 24 patients were enrolled but 4 were excluded because of the lack of adequate venous access or for other reasons.
Arm/Group Title Aliskiren Hydrochlorothiazide
Hide Arm/Group Description

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: 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

Period Title: Overall Study
Started 12 12
Completed 11 9
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             0             1
No possibility to put a catheter             1             2
Arm/Group Title Aliskiren HCTZ Total
Hide Arm/Group Description Patients with essential hypertension stage 1 and 2 . Patients with essential hypertension stage 1 and 2 Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
55.7  (8.6) 49.7  (15) 52.7  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
3
  27.3%
3
  33.3%
6
  30.0%
Male
8
  72.7%
6
  66.7%
14
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
11
 100.0%
8
  88.9%
19
  95.0%
Unknown or Not Reported
0
   0.0%
1
  11.1%
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 11 participants 9 participants 20 participants
11 9 20
blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 11 participants 9 participants 20 participants
150  (10.7) 141  (12.9) 146  (11.5)
1.Primary Outcome
Title Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide
Hide Description Changes in R2* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney
Time Frame week 0 vs week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Hydrochlorothiazide
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: 1/sec
Cortex week 0 20.5  (1) 19.5  (1)
Cortex week 8 19.5  (1) 20.5  (1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Hydrochlorothiazide
Hide Arm/Group Description Aliskiren: Drug therapy has been 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: Drug therapy has been 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.

No side effect were observed and all patients finished the sudy in this treatment arm

All-Cause Mortality
Aliskiren Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aliskiren Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Small number of patients who completed the study. Overall underpowered.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Michel Burnier
Organization: Service of Nephrology, Centre Hospitalier Universitaire Vaudois, Lausanne
Phone: +41 21 314 11 54
EMail: michel.burnier@chuv.ch
Layout table for additonal information
Responsible Party: Michel Burnier, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01519635     History of Changes
Other Study ID Numbers: 2011DR3137
First Submitted: January 6, 2012
First Posted: January 27, 2012
Results First Submitted: July 28, 2016
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019