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Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension (Renin)
This study has been completed.
Sponsor:
Medical University of South Carolina
Collaborator:
New York Presbyterian Hospital
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00684489
First received: February 25, 2008
Last updated: May 22, 2008
Last verified: May 2008
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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:
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.
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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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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More Information
| 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 |
Keywords provided by Medical University of South Carolina:
|
hypertension renin-guided therapeutics |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Coal Tar Hydrochlorothiazide Antihypertensive Agents Keratolytic Agents |
Dermatologic Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 28, 2017