HypertensionReninNCT00684489
Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
A study testing clinical hypertension specialist-no specific med. Any anti-hypertension meds. and renin guided therapeutics-no specific med. Any anti-hypertensive med. in people with Hypertension, run by Medical University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- clinical hypertension specialist-no specific med. Any anti-hypertension meds. and renin guided therapeutics-no specific med. Any anti-hypertensive med.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
About this study
Official title: 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:
- 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.
- 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.
- 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
- Conditions
- Hypertension
- Being tested
- clinical hypertension specialist-no specific med. Any anti-hypertension meds., renin guided therapeutics-no specific med. Any anti-hypertensive med.
- Keywords
- hypertension, renin-guided therapeutics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical hypertension specialist-no specific med. Any anti-hypertension meds.Drug
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.
renin guided therapeutics-no specific med. Any anti-hypertensive med.Drug
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 group | Role | What they receive |
|---|---|---|
| A; B | Active comparator | Not described Receives: Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.; Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med. |
| 2 | Active comparator | Arm A is assignment to a clinical hypertension specialist Arm B is assigned renin-guided therapeutics Receives: Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.; Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med. |
| A is clinical hypertension specialist | Active comparator | Arm A is assigned to a clinical hypertension specialist Receives: Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds. |
| Arm B is renin-guided therapeutics | Active comparator | This group will be assigned to renin-guided therapeutics Receives: Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startSep 2003
- Primary completionMar 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684489
- Sponsor's protocol ID
- 11023
- Other IDs
- HR# 11023
- Acronym
- Renin
- Status last verified
- May 2008
- First submitted
- 25 Feb 2008
- Last updated
- 26 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension
- ClinicalTrials.gov ID
- NCT00684489
- Acronym / sponsor ID
- Renin / 11023
- Conditions
- Hypertension
- Keywords
- hypertension, renin-guided therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Study start
- Sep 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A; B | Active comparator | Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds., Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med. |
| 2 | Active comparator | Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds., Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.Arm A is assignment to a clinical hypertension specialist Arm B is assigned renin-guided therapeutics |
| A is clinical hypertension specialist | Active comparator | Drug: clinical hypertension specialist-no specific med. Any anti-hypertension meds.Arm A is assigned to a clinical hypertension specialist |
| Arm B is renin-guided therapeutics | Active comparator | Drug: renin guided therapeutics-no specific med. Any anti-hypertensive med.This group will be assigned to renin-guided therapeutics |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 2, A is clinical hypertension specialist, A; B |
| 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. | Drug | 2, A; B, Arm B is renin-guided therapeutics |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing clinical hypertension specialist-no specific med. Any anti-hypertension meds. and renin guided therapeutics-no specific med. Any anti-hypertensive med. in people with Hypertension, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2008.