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CompletedNCT00684489ReninUpdated May 26, 2008

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

An interventional study of clinical hypertension specialist-no specific med. Any anti-hypertension meds. and renin guided therapeutics-no specific med. Any anti-hypertensive med. in Hypertension, sponsored by Medical University of South Carolina. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-26.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study 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.
Read the 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

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • renin-guided therapeutics
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 52 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    A; B

    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

    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

    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

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

Interventions

  • Drugclinical 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.

  • Drugrenin 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.

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00684489
Lead sponsor
Medical University of South Carolina
Collaborators
New York Presbyterian Hospital
First posted
May 26, 2008
Start date
Sep 2003
Primary completion
Mar 2005
Completion
Sep 2005
Last update
May 26, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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