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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01519635
First received: January 6, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg (hydrochlorothiazide).


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Aliskiren 300mg and Hydrochlorothiazide 25mg on Kidney Oxygenation in Patients With Stage 1 and 2 Hypertension: a BOLD-MRI Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Renal oxygenation measured by renal BOLD-MRI after chronic treatment with aliskiren or hydrochlorothiazide [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    A renal BOLD-MRI is performed after administration of aliskiren or hydrochlorothiazide and R2* measures are taken. The R2* values of the renal medulla and the renal cortex with both drugs are then compared with each other.


Estimated Enrollment: 36
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aliskiren Drug: 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.
Other Name: Rasilez
Active Comparator: Hydrochlorothiazide Drug: 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.
Other Name: Esidrex

Detailed Description:

36 patients with arterial hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg) will be included in this study and randomized to two groups of 18 patients each: one group will receive RASILEZ 300mg (aliskiren) and one group ESIDREX 25mg (hydrochlorothiazide).

After a two week washout of antihypertensive drugs, baseline and the chronic effect (8 week study drug) of each group will be studied with precise renal hemodynamic measurements (inulin clearance, PAH renal plasma and blood flow, sodium and endogenous lithium excretion, plasma renin, plasma aldosterone, urinary sodium and potassium) and assessment of renal oxygenation with BOLD-MRI (blood oxygen level detection - magnetic resonance imaging).

Drug therapy will be started with an initial 2 weeks on Rasilez 150 mg or HCTZ 12.5 mg followed by a titration to 300 mg Rasilez and 25 mg HCTZ if the treatment is well tolerated. In both groups: 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.

Patients already on treatment with antihypertensive drugs can be included in this study, but will undergo a 'wash-out' period of two weeks. After obtaining informed consent, baseline physical examination and office blood pressure measurement will be performed. Office blood pressure will be measured according to the guidelines of the European Society on Hypertension and European Society of Cardiology (ESH-ESC practice guidelines) by an experienced physician. Moreover, patients will measure their home blood pressure twice daily: after 5 minutes of sitting quietly, three measures spaced by 1-2 minutes will be taken in the morning and in the evening. For this purpose, an Omron 705 IT device will be provided to the participants; this device has been widely tested in clinical practice and has been validated for use in clinical studies (12).

Throughout the study, the participants will continue his/her regular diet. The goal should be to keep the salt intake as stable as possible during the study, since salt intake alters the R2* signal. Salt intake will be verified each time before BOLD-MRI measurement by a 24h urine collection (dosing volume, creatinine- and sodium-concentration).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Tolerance to study drugs
  • Age > 18 years
  • Arteria hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)
  • Normal renal function
  • Availability to give informed consent

Exclusion Criteria:

  • Intolerance to study drugs
  • Renal artery stenosis
  • Hyperkalaemia > 5.0 mmol/l
  • Contra-indications to the use of PAH, inulin or Lithium
  • Asthma
  • Pychiatric illness
  • No estimated easy vascular venous access for placement of two peripherical venous catheters in forearms
  • Contra-indication to MRI-imaging: Claustrophobia or Pacemaker or other implanted metal device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519635

Contacts
Contact: Michel Burnier, Professor 0041213141129 Michel.Burnier@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1004
Contact: Michel Burnier, Professor    0041213141129    michel.burnier@huv.ch   
Sub-Investigator: Valentina Forni, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Michel Burnier, Professor Centre Hospitalier Universitaire Vaudois
  More Information

Publications:
Responsible Party: Michel Burnier, Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01519635     History of Changes
Other Study ID Numbers: 2011DR3137
Study First Received: January 6, 2012
Last Updated: January 27, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Kidney oxygenation
Stage 1 or 2 hypertension
BOLD-IRM

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014