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

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

Tracking Information

• First Submitted Date: February 25, 2008
• First Posted Date: May 26, 2008
• Last Update Posted Date: May 26, 2008
• Study Start Date: September 2003
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 22, 2008): 52
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2005
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00684489
• Other Study ID Numbers: 11023; HR# 11023
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Brent M. Egan, MD, Medical University of South Carolina
• Study Sponsor: Medical University of South Carolina
• Collaborators: New York Presbyterian Hospital
• Investigators: Not Provided
• PRS Account: Medical University of South Carolina
• Verification Date: May 2008