Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension

Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension

Sponsors

Lead Sponsor: Medical University of South Carolina

Collaborator: New York Presbyterian Hospital

Source Medical University of South Carolina
Brief Summary

Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy.2,3 The researchers hypothesize that: 1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by Clinical Hypertension Specialists. 2. Renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more medications, while under the care of a Clinical Hypertension Specialist. 3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

Detailed Description

Hypertension affects ~25% of adults. The prevalence of hypertension and related complications is greater among the elderly, obese, and ethnic minorities. Unfortunately, hypertension control rates remain in the 25% range and are often significantly lower for the high-risk groups noted.1 Since the high-risk groups are growing more rapidly than the general population, the prevalence of hypertension and associated morbidity and mortality will probably increase sharply in the years ahead unless successful strategies are implemented for dramatically improving blood pressure control. Direct measurements of plasma renin reflect the relative balance between volume (V) and vasoconstrictor (renin [R]) factors underlying the elevated blood pressure in patients with essential hypertension.2 While many antihypertensive medications have effects on both the volume (V) and vasoconstrictor (renin [R]) components of elevated blood pressure, one or the other usually predominates

Overall Status Completed
Start Date September 2003
Completion Date September 2005
Primary Completion Date March 2005
Phase N/A
Study Type Interventional
Enrollment 52
Condition
Intervention

Intervention Type: Drug

Intervention Name: clinical hypertension specialist-no specific med. Any anti-hypertension meds.

Description: assignment to a clinical hypertension specialist. Drugs used were hypertension medications were: chlorothiazide, hydrochlorothiazide, polythiazide indapamide, metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene, eplerenone, spironolactone, atenolol, betaxolol, bisoprolol, metoprolol, nadolol, propranolol, timolol, acebutolol, penbutolol pindolol, carvedilol, labetalol, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, diltiazem, dilacor, ditiazem, verapamil, amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, doxazosin, prazosin, terazosin, clonidine, clonidine patch, methyldopa, reserpine, guanfacine, hydralazine, minoxidil.

Intervention Type: Drug

Intervention Name: renin guided therapeutics-no specific med. Any anti-hypertensive med.

Description: renin guided therapeutics-chlorothiazide, chlorthalidone, hydrochlorothiazide, polythiazide, indapamide, metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene, eplerenone, spironolactone, atenolol, betaxolol, bisoprolol, metoprolol, nadolol, propranolol, timolol, acebutolol, penbutolol, pindolol, carvedilol, labetalol, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, diltiazem, dilacor, verapamil, amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, doxazosin, prazosin, terazosin, chlonidine, methyldopa, reserpine, guanfacine, hydralazine, minoxidil.

Eligibility

Criteria:

Inclusion Criteria: - Age, 21 years of age and older - Male or female (post-menopausal or effective method of birth control) - BP and treatment criteria noted above - Willingness to provide written, informed consent - Ability to adhere to study protocol Exclusion Criteria: - Uncontrolled diabetes or hyperlipidemia requiring medication changes - Any active disease process requiring new diagnostic and therapeutic plans - Any life-threatening illness - History of alcohol or drug abuse in past 5 years - Mental illness or personality disorder that interfere with adherence to study protocol - Serum creatinine >2.5 mg/dL unless documented stable for at least one year - Dialysis for chronic renal failure, even if creatinine stable for at least one year - Intolerance to two or more classes of antihypertensive medications - Normal home BP (<140/90 mmHg at baseline), i.e., office only hypertension.

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

May 2008

Responsible Party

Name Title: Brent M. Egan, MD

Organization: Medical University of South Carolina

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: A; B

Type: Active Comparator

Label: 2

Type: Active Comparator

Description: Arm A is assignment to a clinical hypertension specialist Arm B is assigned renin-guided therapeutics

Label: A is clinical hypertension specialist

Type: Active Comparator

Description: Arm A is assigned to a clinical hypertension specialist

Label: Arm B is renin-guided therapeutics

Type: Active Comparator

Description: This group will be assigned to renin-guided therapeutics

Acronym Renin
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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