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Device
Baroreflex Activation Therapy for Heart Failure (BeAT-HF Trial)
N/A
Waitlist Available
Led By William Abraham, MD
Research Sponsored by CVRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trialwill research a device to help treat heart failure. Subjects will be monitored for up to 5 years.
Eligible Conditions
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Cardiovascular system
Heart failure
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Device and Medical ManagementExperimental Treatment2 Interventions
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Group II: Medical ManagementActive Control1 Intervention
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Management
2013
Completed Phase 4
~3060
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Who is running the clinical trial?
CVRx, Inc.Lead Sponsor
20 Previous Clinical Trials
7,331 Total Patients Enrolled
11 Trials studying Heart Failure
6,052 Patients Enrolled for Heart Failure
Michael Zile, MDStudy ChairMedical University of South Carolina
4 Previous Clinical Trials
237 Total Patients Enrolled
4 Trials studying Heart Failure
237 Patients Enrolled for Heart Failure
William Abraham, MDPrincipal InvestigatorOhio State University
10 Previous Clinical Trials
3,944 Total Patients Enrolled
8 Trials studying Heart Failure
3,884 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a certain type of heart therapy called cardiac resynchronization therapy (CRT) within the last six months.You currently need a specific heart device for treating heart failure, according to medical guidelines.You have a condition that affects your body's ability to regulate blood pressure or nerve function.You have severe heart failure within the past 45 days before starting the study.You have a very high body mass index.Your kidney function is very low, based on a blood test done within the last 45 days.You have had frequent low blood pressure and felt symptoms from it in the 45 days before the study starts.Your heart rate at rest is consistently too fast (over 100 beats per minute) or too slow (less than 60 beats per minute) when measured at the clinic.You have serious heart rhythm problems that are not well controlled or stable.You had severe heart failure with lung fluid buildup in the past 45 days.You have been diagnosed with moderate to severe heart failure (NYHA Class II or III) within the past 3 months.You can walk between 150 and 400 meters in six minutes.You have had a heart attack, stroke, organ transplant, or certain other serious medical conditions within the last 3 months. You are currently being treated for certain heart conditions, receiving certain therapies, or have a life expectancy of less than one year. You also have a significant psychological condition or are unable to follow the study's requirements.Your heart's pumping ability is less than 35% within 45 days before starting the study.You have had heart failure and your NT-proBNP levels are above a certain range, or you have had a heart failure hospitalization in the past year.The artery where the BAROSTIM implant will be placed must meet certain requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Device and Medical Management
- Group 2: Medical Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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