Status:
COMPLETED
Role of Sleep Apnea and Sympathetic Activity in Resistant Hypertensive Patients.
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Type 2 Diabetes
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Hypertension is highly prevalent in type 2 diabetic patients (NIDDM) with nephropathy, and is the single most important determinant of the rate of renal function loss. In many of these patients, hyper...
Detailed Description
The study will be double blind and consist of two parallel groups. Patients with type 2 diabetes with a creatinine clearance above 20 ml/min and with microalbuminuria or proteinuria who have both resi...
Eligibility Criteria
Inclusion
- .
- Males and females 18 years or older
- On 3 or more antihypertensive medications with resistant hypertension of \>140/90 mmHg (resting) despite treatment
- Diagnosis of sleep apnea (15 apneic/hypopneic episodes per hour and a score of 10 on Epworth sleepiness scale).
- Creatinine clearance \> 20 ml/min with microalbuminuria or proteinuria, (results within past 6 months)
Exclusion
- Acute coronary syndrome within 6 months
- Patients with clinically documented congestive heart failure
- Patients with relevant cardiac arrhythmias (second and third-degree heart block or premature ventricular complexes in Lown classes IV or V)
- Pregnant or lactating women
- Patients with leg injury involving nerve damage
- Patients with symptomatic peripheral neuropathy
- Patients with predominant central sleep apnea
- Patients mentally unable to give informed consent
- Professional drivers
- Patients with a resting blood pressure \>180/110 mmHg
- Patients taking clonidine
- Patients with sleep apnea causing daily drowsiness
- Patients with severe hyperkalemia (\>5.5 mmol/L) or hypokalemia (\<3.3 mmol/L)
- Patients with a BMI of \>35
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01875341
Start Date
December 1 2004
End Date
February 1 2015
Last Update
February 10 2015
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9