Official Title: “Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: March 2005

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

Intervention(s) in this Clinical Trial

• Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.
  • 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.
• Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A; B
• Active Comparator: 2
  • Arm A is assignment to a clinical hypertension specialist Arm B is assigned renin-guided therapeutics
• Active Comparator: A is clinical hypertension specialist
  • Arm A is assigned to a clinical hypertension specialist
• Active Comparator: Arm B is renin-guided therapeutics
  • This group will be assigned to renin-guided therapeutics

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Medical University of South Carolina

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00684489

Study ID Number: 11023

ClinicalTrials.gov Identifier: NCT00684489

Health Authority: United States: Institutional Review Board