NCT01519635

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Oct 2011

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

January 6, 2012

Results QC Date

July 28, 2016

Last Update Submit

March 3, 2020

Conditions

Hypertension

Keywords

Kidney oxygenationStage 1 or 2 hypertensionBOLD-IRM

Outcome Measures

Primary Outcomes (1)

  • Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide

    Changes in R2\* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney

    week 0 vs week 8

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR

Aliskiren 150 to 300 mg once a Week for 8 weeks

Drug: Aliskiren

Hydrochlorothiazide

ACTIVE COMPARATOR

HCTZ 12.5 - 25 mg/d once a day for 8 weeks

Drug: Hydrochlorothiazide

Interventions

AliskirenDRUG

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.

Also known as: Rasilez
Aliskiren
HydrochlorothiazideDRUG

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.

Also known as: Esidrex
Hydrochlorothiazide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 20308608BACKGROUND

  • Vakilzadeh N, Muller ME, Forni V, Milani B, Hoffman L, Piskunowicz M, Maillard M, Zweiacker C, Pruijm M, Burnier M. Comparative Effect of a Renin Inhibitor and a Thiazide Diuretic on Renal Tissue Oxygenation in Hypertensive Patients. Kidney Blood Press Res. 2015;40(5):542-54. doi: 10.1159/000368530. Epub 2015 Oct 26.

    PMID: 26501147RESULT

MeSH Terms

Conditions

Hypertension

Interventions

aliskirenHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Small number of patients who completed the study. Overall underpowered.

Results Point of Contact

Title
Prof Michel Burnier
Organization
Service of Nephrology, Centre Hospitalier Universitaire Vaudois, Lausanne
michel.burnier@chuv.ch
+41 21 314 11 54

Study Officials

  • Michel Burnier, Professor

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 27, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 17, 2020

Results First Posted

September 6, 2019

Record last verified: 2020-03

Locations

CH(1)