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

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ClinicalTrials.gov Identifier: NCT00684489
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 26, 2008
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE May 26, 2008
Last Update Posted Date May 26, 2008
Study Start Date  ICMJE September 2003
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
Official Title  ICMJE Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension
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. 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2008)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00684489
Other Study ID Numbers  ICMJE 11023
HR# 11023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brent M. Egan, MD, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE New York Presbyterian Hospital
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date May 2008

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