Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure
Study Details
Study Description
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 primary aim of this study is to identify patients of the whole HFrEF population that are most likely to benefit from this new promising therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 quality of life. Yet it is unknown which pts of the whole HFrEF population are most likely to benefit from this new promising therapy. As this invasive technique should definitely not be proposed for all HFrEF pts with left ventricular ejection fraction of 35 % or less the aim of this single center prospective clinical trial is to evaluate to which extent possible factors (e.g. cardiac resynchronization therapy (CRT), atrial fibrillation) may influence the response to BAT. To analyze any possible differences concerning the modulation of the autonomic nervous system caused by BAT in the presence of atrial fibrillation or cardiac resynchronization therapy, heart rate variability (HRV) analyses will be performed additionally. As autonomic nervous activity plays a pivotal role in the genesis and termination of atrial fibrillation any possible impact of baroreflex activation therapy on atrial fibrillation will be examined.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in left ventricular ejection fraction [measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation]
- Change in Quality of life [assessed baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation]
- Change in NYHA functional class ranking [measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation]
- Chance in exercise capacity (distance walked in 6 min) [measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation]
- Change in N-terminal pro-brain natriuretic peptide [measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation]
Eligibility Criteria
Criteria
Inclusion Criteria:
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chronic heart failure (NYHA functional class III)
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LVEF of 35% or less
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chronic stable Guideline-directed medical therapy (diuretic agent, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and a beta blocker, if tolerated)
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resting heart rate between 60 and 100 beats/min
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systolic blood pressure of at least 100 mmHg
Exclusion Criteria:
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estimated glomerular filtration rate < 30 ml/min/1.73 m²
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Plaque and atherosclerosis reducing the linear diameter of the internal or distal common carotid arteries by 50% or more
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acute pulmonary edema within the last six weeks
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implantation of Pacemakers, ICDs or CRTs within the last 3 months or planned for the next three months
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life expectancy < 1 year
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body mass index > 40 kg/m²
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symptomatic uncontrolled bradyarrhythmias
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severe asthma, chronic obstructive pulmonary disease or restrictive lung disease
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active malignancy
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pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany | 32545 |
Sponsors and Collaborators
- Heart and Diabetes Center North-Rhine Westfalia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HDZ-KA_012_DG