Phase 4 N=24 Randomized Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01519635 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide — 20.5; 19.5; 19.5; 20.5 1/sec

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aliskiren (Drug); Hydrochlorothiazide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Centre Hospitalier Universitaire Vaudois
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide	20.5; 19.5; 19.5; 20.5	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01519635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.