Status:
TERMINATED
Combined Renin Inhibition/Beta-blockade
Lead Sponsor:
The Rogosin Institute
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Antihypertensive drug treatment is effective in only about 50% of patients. One mechanism responsible for treatment failure is a drug related stimulation of the renin-angiotension-aldosterone-system (...
Detailed Description
The renin-angiotensin-aldosterone system (RAAS) plays a central role in the maintenance of normal blood pressure (BP) homeostasis. Derangements in the regulation of this system, predominantly due to t...
Eligibility Criteria
Inclusion
- Twenty subjects with a history of hypertension with the following inclusion criteria will be enrolled:
- Age 18-80 years
- Stage 1 (systolic 140-159 mm Hg or diastolic 90-99 mmHg) or Stage 2 (systolic \>160 mm Hg or diastolic \>100 mmHg) or current treatment with antihypertensive medication.
- PRA ≥0.65 ng/ml/h. If PRA is below this level during the screening period, due to treatment with a beta-blocker or central α2-receptor agonist, the subject may be enrolled and the PRA level re-checked after treatment is tapered off.
Exclusion
- History of diabetes requiring pharmacologic treatment with an oral or parenteral hypoglycemic agent, including insulin
- TIA, stroke or myocardial infarction
- History of asthma or COPD
- Cockcroft Gault estimated GFR \<60 ml/min/1.73 m2
- Previous adverse events during treatment with a β-blocker or aliskiren
- ALT level twice normal
- Secondary forms of hypertension (e.g., renovascular, primary aldosteronism)
- PRA\<0.65 ng/ml/h after discontinuation of antihypertensive medication
- Systolic BP\>180 mm Hg, diastolic BP\>105 mm Hg
- Pregnant or breastfeeding, or planning pregnancy during the study period
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00627861
Start Date
November 1 2008
End Date
May 1 2010
Last Update
November 24 2015
Active Locations (1)
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1
The Rogosin Institute
New York, New York, United States, 10021