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

Purpose

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:

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.
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.
Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Enrollment:	52
Study Start Date:	September 2003
Study Completion Date:	September 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

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

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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Brent M. Egan, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00684489 History of Changes
Other Study ID Numbers:	11023, HR# 11023
Study First Received:	February 25, 2008
Last Updated:	May 22, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

hypertension
renin-guided therapeutics

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013