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

January 6, 2012
January 27, 2012
October 2011
October 2012   (final data collection date for primary outcome measure)
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.
Renal oxygenation measured by renal BOLD-MRI after chronic treatment with aliskiren or hydrochlorotiazide [ Time Frame: up to one year ] [ Designated as safety issue: No ]
A renal BOLD-MRI is performed after administration of aliskiren or hydrochlorotiazide 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.
Complete list of historical versions of study NCT01519635 on ClinicalTrials.gov Archive Site
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Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension
Effect of Aliskiren 300mg and Hydrochlorothiazide 25mg on Kidney Oxygenation in Patients With Stage 1 and 2 Hypertension: a BOLD-MRI Study

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).

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
  • 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
  • Active Comparator: Aliskiren
    Intervention: Drug: Aliskiren
  • Active Comparator: Hydrochlorothiazide
    Intervention: Drug: Hydrochlorothiazide
Pruijm M, Hofmann L, Maillard M, Tremblay S, Glatz N, Wuerzner G, Burnier M, Vogt B. Effect of sodium loading/depletion on renal oxygenation in young normotensive and hypertensive men. Hypertension. 2010 May;55(5):1116-22. doi: 10.1161/HYPERTENSIONAHA.109.149682. Epub 2010 Mar 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Michel Burnier, Professor 0041213141129 Michel.Burnier@chuv.ch
Switzerland
 
NCT01519635
2011DR3137
Yes
Michel Burnier, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Not Provided
Principal Investigator: Michel Burnier, Professor Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP