Treatment for Hypertension

Phase-Based Estimates
1
Effectiveness
2
Safety
Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, IN
Hypertension+5 More
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether erythropoietin may have positive impacts for individuals with chronic kidney disease.

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Eligible Conditions

  • Hypertension
  • Kidney Diseases
  • Anemia
  • Chronic Kidney Diseases
  • Chronic Kidney Disease (CKD)
  • Blood Pressures
  • Renal Insufficiency, Chronic

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes and 3 secondary outcomes in patients with Hypertension. Measurement will happen over the course of Baseline to 4 weeks.

Baseline to 12 weeks
Between group change in hypertension status
Change in diastolic blood pressure in EPO treated patients compared to delayed start controls
Change in systolic blood pressure in EPO treated patients
Baseline to 4 weeks
Change in flow mediated dilatation (FMD)
Oxygen-induced change in forearm blood flow (OIC-FBF)
Predictors of change in flow mediated dilatation (FMD)
Week 24
Within group change in hypertension status

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Groups

Early start

This trial requires 160 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Early start
Drug
Participants given study drug immediately at randomization

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 weeks vs 12 weeks to 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 12 weeks vs 12 weeks to 24 weeks for reporting.

Closest Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stage 3 or 4 chronic kidney disease
You have uncontrolled hypertension with 24 hour ambulatory blood pressure monitoring. show original
You are not treated with erythropoiesis-stimulating agents (ESA) within 3 months. show original
You have hemoglobin between 8 and 10 g/dL. 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.

Have there been other clinical trials involving treatment?

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Since a combination of medications may be used during treatment in the patients selected for this study, it is not impossible that the results obtained by others may be different.

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What causes hypertension?

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Most hypertension is not caused by high levels of blood pressure: some form of cardiovascular disease causes most cases when they are detectable. Diabetes mellitus is a common cause of elevated blood pressure among the elderly.

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What is hypertension?

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A large and growing body of clinical and laboratory evidence, mainly in adults, points to hypertension as being a risk factor for atherosclerosis and its pathological complications.

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What are the signs of hypertension?

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Hypertension is usually asymptomatic until it is advanced enough to cause symptoms such as claudication of the renal arteries. The first sign may be lower extremity swelling or tenderness to pressure, but there may also be at least some kidney stone formation in the kidney.

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Can hypertension be cured?

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The most effective treatments for high blood pressure are lifestyle changes, namely exercise, weight control and a healthy diet, when coupled with antihypertensive therapy. Other treatments such as antihypertensives may be ineffective if a person's risk factors for heart disease, stroke or dementia persist. Further research into alternative therapeutic options and approaches in the prevention and management of blood pressure is encouraged.

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

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About 60 million US adults have been advised by a doctor to change some way of life to lower blood pressure. In the United States, approximately 18% of men and 20% of women are estimated to have high blood pressure, so between 50 and 66 million adults are at high risk.

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What are common treatments for hypertension?

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While hypertension is often treated with various medications and/or lifestyle changes, physical activity and/or weight reduction are efficacious lifestyle choices in reducing hypertension and are associated with improving quality of life.

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What does treatment usually treat?

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It is evident that a substantial number of patients are treated empirically, perhaps for reasons other than the severity of their condition. As a percentage of all patients presenting with hypertension, about 40% will have a treatment indication, which is an important consideration. The percentage of patients treated empirically is highest in those with hypertension that is not controlled on pharmacological treatment as their treatment indication.

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How does treatment work?

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Treatment of hypertension with or without medication, with the recommended dose over a 1-year period in a primary care setting, can achieve blood pressure goal, or be achieved more commonly in other healthcare settings. It is not necessarily possible to attribute any particular treatment to any one effector (biomechanical) or to any one mechanism of change (biologic).

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Does hypertension run in families?

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Significant heritability was found herein. Significant gene x environment interaction for diastolic blood pressure was also found in both fathers and mothers. There is a need for further genetic studies in both fathers and mothers to elucidate the genetic susceptibility to offspring hypertensive risk.

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What is treatment?

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The goal of therapy for secondary hypertension is to achieve control of blood pressure and prevent additional damage to the circulatory system due to the adverse effects of elevated blood pressure on vessel walls and kidneys. Thus, therapy will vary depending upon the level of blood pressure, the cause(s) of secondary hypertension, and the individual presenting with clinical symptoms and signs of hypertension.\n\nThe International Classification of Functioning, Disability and Health (ICF) is a comprehensive, WHO-wide, systematic approach towards the conceptualization, classification and description of health conditions, in both diagnosis and rehabilitation. The first edition was published in 2001, and a revised second edition was released in April 2012.

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What are the common side effects of treatment?

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A range of side effects have been described with conventional hypertension medications. The occurrence of side effects varies with each medication and, therefore, it is unwise to generalize. It may be of particular concern for younger patients since they are typically more frail and prone to drug-related side effects. Physicians may wish to discuss the specific pharmacology of relevant drugs with their patients before prescribing a particular drug, particularly those that may be associated with side effects common to an entire class of drugs, such as those affecting calcium homeostasis. Most side effects involve either the drug itself and/or its metabolism or the drug's pharmacology. Because of this, some side effects can be managed by changing the way the drug is taken.

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