Combined Renin Inhibition/Beta-blockade

Stopped early · Not applicable

Conditions studied: Hypertension

In brief

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 (RAAS). Several classes of medications that treat hypertension by blocking the RAAS system have been developed. However, the kidney responds to these drug treatments by producing greater amounts of renin. This high level of renin can reduce the effectiveness of some of these medications, ultimately causing the blood pressure to rise. This is one reason why blood pressure can be difficult to control in a certain percentage of patients. The hypothesis to be tested in the proposed study is that beta-adrenergic blockade (β-blockade), when superimposed upon aliskiren, a drug that competitively inhibits plasma renin activity (PRA) but stimulates the release of renin by the kidneys (plasma renin concentration \[PRC\]), can suppress the reactive increase in PRC that occurs during aliskiren monotherapy. The primary aim of this study is to measure plasma renin concentration (PRC) and plasma renin activity (PRA) levels during renin inhibition with aliskiren and combined renin inhibition/β-blocker treatment to determine whether the addition of a β-blocker attenuates the rise in plasma renin concentration (PRC). A secondary aim is to determine whether combined treatment further suppresses PRA and blood pressure.

Key facts

Study ID

NCT00627861

Run by

The Rogosin Institute

People needed

1

Starts

2008-11-01

Expected to finish

2010-05-01

Last updated by the study team

2015-11-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Rogosin Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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