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

NCT00684489 | Completed

• 2 other identifiers: 11023HR# 11023
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Keywords

hypertension; renin-guided therapeutics

Study Arms (4)

A; B

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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.; Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.

A is clinical hypertension specialist

ACTIVE COMPARATOR

Arm A is assigned to a clinical hypertension specialist

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

Arm B is renin-guided therapeutics

ACTIVE COMPARATOR

This group will be assigned to renin-guided therapeutics

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

Interventions

clinical hypertension specialist-no specific med. Any anti-hypertension meds. DRUG

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.

2; A is clinical hypertension specialist; A; B

renin guided therapeutics-no specific med. Any anti-hypertensive med. DRUG

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.

2; A; B; Arm B is renin-guided therapeutics

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• New York Presbyterian Hospital: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: May 26, 2008
• Study Start: September 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: September 1, 2005
• Last Updated: May 26, 2008

Record last verified: 2008-05