Dehydrated alcohol for Hypertension

Phase-Based Estimates
2
Effectiveness
3
Safety
Cardiology PC, Birmingham, AL
Hypertension
Dehydrated alcohol - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether a procedure which blocks bloodflow to a certain part of the kidney may help treat high blood pressure.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Dehydrated alcohol will improve 1 primary outcome and 22 secondary outcomes in patients with Hypertension. Measurement will happen over the course of Procedure date (day 0).

3 and 6 months
Change in mean daytime ambulatory DBP
Change in mean nighttime ambulatory DBP
Change in mean nighttime ambulatory SBP
Change of 24-hour mean diastolic ABPM
Change of diastolic office blood pressure
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure
Changes in eGFR
Decrease in eGFR > 25%
3 months
ABPM responders (5 mmHg)
Change in mean systolic ABPM
Changes in antihypertensive regimen
Office BP responders (10 mmHg)
Month 12
Reduction of office SBP and DBP to normal
Year 3
Major Adverse Events
30 days
Proportion of subjects with major adverse events
6 months
Change in mean daytime ambulatory SBP
Change in mean office SBP
Change of 24-hour mean systolic ABPM
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure
8 weeks
Change of office systolic blood pressure
Day 1
Procedure success
Procedure date (day 0)
Device success
Year 3
Adverse event rate

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Renal Angiography Only (Sham Procedure)
Treated with Peregrine System Kit
Placebo group

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dehydrated Alcohol is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Treated with Peregrine System Kit
Drug
The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.
Renal Angiography Only (Sham Procedure)
Device
The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, and 12 months and 2 and 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, and 12 months and 2 and 3 years for reporting.

Closest Location

Cardiology PC - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This patient has severe hypertension, as evidenced by three office blood pressure measurements with a mean SBP of ≥150 mmHg and ≤180 mmHg, AND a mean DBP of ≥90 mmHg when receiving 2 to 5 antihypertensive medications. show original
on two consecutive days The average 24-hour ambulatory SBP is ≥135 mmHg and ≤170 mmHg, with ≥70% valid readings on two consecutive days. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hypertension?

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Some signs of hypertension include lack of effort in work, or tiredness during work. More than half of people with hypertension also report feeling dizzy or lightheaded when standing up from a seated or recumbent position.

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What causes hypertension?

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It is difficult to determine why hypertensive individuals may not be diagnosed and treated, but some risk factors are known. These may include those outlined below. Many of these risk factors are modifiable by lifestyle changes, physical activity, and weight loss. However, it is also important to make sure that lifestyle changes do not worsen the problem, and to make sure that people with hypertension are treated successfully and thoroughly.

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What is hypertension?

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Hypertension is defined as high blood pressure that is consistently well controlled at home or work. In the U.S. approximately 1.6 billion adults have high blood pressure. Hypertension is the leading risk factor for cardiovascular disease. Hypertension is strongly defined by race and ethnicity.

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What are common treatments for hypertension?

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Only a minority of people with hypertension need medication. Most treatments involve lifestyle changes, and medications can be more effective if used at the early stages of hypertension.

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How many people get hypertension a year in the United States?

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More males have hypertension than females. The prevalence estimates among various ethnicities are comparable to estimates on the prevalence of hypertension in the population in the United States. There are clear links between hypertension and coronary diseases in all ethnic groups with the exception of the Asians.

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Can hypertension be cured?

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A single-drug treatment of diuretics and calcium channel blockers combined with lifestyle intervention reduces systolic blood pressures significantly more than a placebo or only low-pressure dietary regimen. The therapeutic effect of blood pressure reduction does not worsen diabetes-related complications of hypertension.

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Is dehydrated alcohol typically used in combination with any other treatments?

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Alcoholic beverages have some beneficial effects when used in combination with other treatments. On the other hand, alcohol is associated with adverse effects when used in combination with benzodiazepines as well as other treatments.

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Is dehydrated alcohol safe for people?

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The use of low-potency alcohol (> 20% alcohol by volume) prior to surgery may have a similar adverse influence on postoperative health as a high-potency agent in an anaesthetic.

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Does dehydrated alcohol improve quality of life for those with hypertension?

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Data from a recent study was conducted in a convenience sample. The impact of alcohol consumption on quality of life for patients with hypertension warrants further study.

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What is the latest research for hypertension?

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The prevalence and mortality of hypertension has fallen between 1986 and 2006. Prevention and treatment of hypertension will require an integrated approach but will be a challenging task.

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Who should consider clinical trials for hypertension?

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The authors found that no patient has a higher QALY than a clinician. Only when the QALYs of patients exceed those of clinicians are the patients considered "cost-effective" to treatment with antihypertensive medications. Clinical trials involving patients have important implications for treatment guidelines and payers because it may affect the cost-benefit ratio of antihypertensive therapy in terms of the number of patient lives saved versus patient-related quality of life and drug prices.

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What is the average age someone gets hypertension?

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Overall the incidence of HT is low, but most of the cases occur for the elderly. The age group with highest incidence is people 40-year-old and over. More female than male people are diagnosed with HT.

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