Renal Denervation for Cardiovascular Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Swedish Health Services, Seattle, WA
Cardiovascular Diseases+3 More
Renal Denervation - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

RADIANCE Continued Access Protocol

See full description

Eligible Conditions

  • Cardiovascular Diseases
  • Hypertension Resistant To Conventional Therapy
  • Hypertension
  • Vascular Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cardiovascular Diseases

Study Objectives

This trial is evaluating whether Renal Denervation will improve 2 primary outcomes and 5 secondary outcomes in patients with Cardiovascular Diseases. Measurement will happen over the course of From baseline to 2 months post procedure.

Month 2
Change in average home systolic/diastolic BP
Change in average office systolic/diastolic BP
Month 6
Change in average daytime/24-hr/night-time ambulatory systolic BP
Month 2
Change in average 24-hr/night-time ambulatory systolic BP
Change in average daytime ambulatory systolic BP
Month 60
Incidence of Adverse Events
Month 2
Change in average 24-hr/night-time ambulatory diastolic BP

Trial Safety

Safety Progress

1 of 3

Other trials for Cardiovascular Diseases

Trial Design

1 Treatment Group

Renal Denervation
1 of 1
Experimental Treatment

This trial requires 300 total participants across 1 different treatment group

This trial involves a single treatment. Renal Denervation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Renal Denervation
Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Denervation
2013
Completed Early Phase 1
~250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure for reporting.

Closest Location

Swedish Health Services - Seattle, WA

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:
Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Patient Q&A Section

What causes cardiovascular diseases?

"The main risk factors for cardiovascular disease are: the size of the heart; elevated blood pressure; high levels of blood sugar and low levels of blood cholesterol. People living in warmer climates are at an elevated risk of heart disease due to the effect of climate on their blood sugar levels, and elevated levels of blood cholesterol. Smoking, alcohol, dietary fat and sugar and the presence of atherosclerosis, can also result in heart disease.\n" - Anonymous Online Contributor

Unverified Answer

How many people get cardiovascular diseases a year in the United States?

"The prevalence of vascular disease is increasing (especially among older persons), as is the magnitude of that increase. As a part of an overall population-based approach, screening for vascular disease should be emphasized. Physicians should play a role in the prevention of cardiovascular disease." - Anonymous Online Contributor

Unverified Answer

What is cardiovascular diseases?

"A total of 11,000 deaths occur every day – of which approximately half are due to cardiovascular diseases. Chronic and debilitating diseases, like cancer, Alzheimer's disease and cardiovascular disease, cause considerable suffering and social and economic losses." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiovascular diseases?

"Cardiovascular signs include palpitations, shortness of breath, palpitations, chest pain, palpitations, heart palpitations, abnormal heart rhythms or palpitations, shortness of breath, lightheadedness or syncope and swelling to the legs, ankles or feet." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cardiovascular diseases?

"Antiacids and the long-term use of aspirin and other anti-inflammatory drugs may be useful in the prevention of cardiovascular diseases. For patients with heart attack or stroke, folic acid, a drug approved by the Food and Drug Advisory Committee of the Food and Drug Administration (FDA), is widely recommended for consumers. Oral statins (atorvirate, lipitor, etc.) may improve outcome. Statins have also been studied as a therapy for cancer prevention, with mixed results. Statins are contraindicated in patients with an acute coronary syndrome or the need for cardiothoracic surgery, among other things." - Anonymous Online Contributor

Unverified Answer

Can cardiovascular diseases be cured?

"In some cases, it is possible to eradicate cardiovascular disease, but it is more efficient to prevent it, and to promote a healthy lifestyle. A balanced diet and regular physical exercise are the best choices to maintain proper cardiovascular health, as they have negative effects on cardiovascular disease as well as being affordable and easily accessible." - Anonymous Online Contributor

Unverified Answer

Is renal denervation typically used in combination with any other treatments?

"The role of RDN for the treatment of HF is expanding. There was a significant paucity of information regarding use in combination with CABG or pacemaking." - Anonymous Online Contributor

Unverified Answer

What does renal denervation usually treat?

"RDA is an effective and safe surgical procedure that can reduce many of the physiological and pathological symptoms of heart failure. It has also been proven to improve the survival rate of patients who suffer from heart failure and is used as salvage or alternative therapy for patients who have other treatments that cannot control symptoms or reverse the underlying cause of their condition. However, there are some adverse effects that can occur after this surgery including bleeding and an increased risk of developing an atrial fibrillation. These risks can be minimized if patients are given proper post-operative care. Patients should return regularly to the hospital to perform cardiac assessments, so as to ensure that their condition is adequately managed. If any problem appear during the procedure, then one must take it seriously." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in renal denervation for therapeutic use?

"Current research in renal denervation uses different techniques. While some authors suggest that denervation is efficient in certain circumstances, others report conflicting results for these same circumstances. Current results indicate that a clear evidence based on large multicenter studies, randomized controlled trials, in line with the currently established indications, is the only acceptable way of proving the efficiency." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cardiovascular diseases?

"Recent advancements in cardiovascular science have led to better patient care in the treatment of a number of cardiovascular conditions. There are many treatment options for the management of [congestive heart failure] (CHF), and as cardiovascular conditions become more and more manageable, better quality of life continues to improve. There are specific therapies that have been shown to improve patient outcomes. [Recently, the use of cardiac stem cells (CSCs) has also been shown to increase cardioprotection, improve remodeling, and reduce LV systolic function after [myocardial infarction"" - Anonymous Online Contributor

Unverified Answer

What are the common side effects of renal denervation?

"Data from a recent study suggest that the safety margin for renal denervation for cardiovascular disease risk reduction is very narrow. Thus, clinical practice should consider the magnitude of the desired effect and risk-outcomes balance in particular patients before renal denervation for managing hypertension." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cardiovascular diseases?

"Until now, the main treatments only target coronary vasoconstriction; however, our study suggests that there is scope for investigating other complementary therapeutic approaches to treat hypertension as well as prevention of atherosclerosis, the main cause of cardiovascular disease." - Anonymous Online Contributor

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