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

This study has been completed.
Sponsor:
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

February 25, 2008
May 22, 2008
September 2003
March 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00684489 on ClinicalTrials.gov Archive Site
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Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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; B
    Interventions:
    • Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.
    • Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.
  • Active Comparator: 2
    Arm A is assignment to a clinical hypertension specialist Arm B is assigned renin-guided therapeutics
    Interventions:
    • Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.
    • Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.
  • Active Comparator: A is clinical hypertension specialist
    Arm A is assigned to a clinical hypertension specialist
    Intervention: Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.
  • Active Comparator: Arm B is renin-guided therapeutics
    This group will be assigned to renin-guided therapeutics
    Intervention: Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2005
March 2005   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00684489
11023, HR# 11023
No
Brent M. Egan, MD, Medical University of South Carolina
Medical University of South Carolina
New York Presbyterian Hospital
Not Provided
Medical University of South Carolina
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP