Status:
COMPLETED
Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure
Lead Sponsor:
Heart and Diabetes Center North-Rhine Westfalia
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this single center prospective clinical trial is to evaluate the safety and efficacy of carotid Baroreflex Activation Therapy (BAT) in advanced heart failure (HFrEF). Beyond that, the...
Detailed Description
Baroreflex activation therapy (BAT) is a new treatment option for patients (pts) suffering from heart failure with reduced left ventricular ejection fraction (HFrEF) to improve functional status and q...
Eligibility Criteria
Inclusion
- chronic heart failure (NYHA functional class III)
- LVEF of 35% or less
- chronic stable Guideline-directed medical therapy (diuretic agent, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and a beta blocker, if tolerated)
- resting heart rate between 60 and 100 beats/min
- systolic blood pressure of at least 100 mmHg
Exclusion
- estimated glomerular filtration rate \< 30 ml/min/1.73 m²
- Plaque and atherosclerosis reducing the linear diameter of the internal or distal common carotid arteries by 50% or more
- acute pulmonary edema within the last six weeks
- implantation of Pacemakers, ICDs or CRTs within the last 3 months or planned for the next three months
- life expectancy \< 1 year
- body mass index \> 40 kg/m²
- symptomatic uncontrolled bradyarrhythmias
- severe asthma, chronic obstructive pulmonary disease or restrictive lung disease
- active malignancy
- pregnancy
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03230643
Start Date
August 1 2017
End Date
May 31 2020
Last Update
August 7 2020
Active Locations (1)
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1
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545