Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: clinical hypertension specialist-no specific med. Any anti-hypertension meds. (Drug); renin guided therapeutics-no specific med. Any anti-hypertensive med. (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical University of South Carolina
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.
Clinical Details
Official title: Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: May 22, 2008
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