Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230643
• Other study ID #: HDZ-KA_012_DG
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Barostim neo implantation
The Barostim neo Implantation is a new promising treatment option for patients with advanced heart failure (HEFrEF) as it might improve cardiac and vascular function by restoring sympathovagal-balance through its effects on the autonomic nervous system. In this observational study, data from patients who have received the Barostim neo System as part of clinical routine will be collected and analyzed. The implantation of this new device is not part of the study.

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JA — View Citation

Dai M, Bao M, Zhang Y, Yu L, Cao Q, Tang Y, Huang H, Wang X, Hu D, Huang C. Low-level carotid baroreflex stimulation suppresses atrial fibrillation by inhibiting left stellate ganglion activity in an acute canine model. Heart Rhythm. 2016 Nov;13(11):2203- — View Citation

DeMazumder D, Kass DA, O'Rourke B, Tomaselli GF. Cardiac resynchronization therapy restores sympathovagal balance in the failing heart by differential remodeling of cholinergic signaling. Circ Res. 2015 May 8;116(10):1691-9. doi: 10.1161/CIRCRESAHA.116.30 — View Citation

Fantoni C, Raffa S, Regoli F, Giraldi F, La Rovere MT, Prentice J, Pastori F, Fratini S, Salerno-Uriarte JA, Klein HU, Auricchio A. Cardiac resynchronization therapy improves heart rate profile and heart rate variability of patients with moderate to sever — View Citation

Gronda E, Seravalle G, Trevano FQ, Costantino G, Casini A, Alsheraei A, Lovett EG, Vanoli E, Mancia G, Grassi G. Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. J Hypertens. 2015 A — View Citation

Huang JH, Lin YK, Hsieh MH, Chen SA, Chiu WC, Chen YJ. Modulation of Autonomic Nervous Activity in the Termination of Paroxysmal Atrial Fibrillation. Pacing Clin Electrophysiol. 2017 Apr;40(4):401-408. doi: 10.1111/pace.13045. Epub 2017 Mar 3. — View Citation

Linz D, Hohl M, Khoshkish S, Mahfoud F, Ukena C, Neuberger HR, Wirth K, Böhm M. Low-Level But Not High-Level Baroreceptor Stimulation Inhibits Atrial Fibrillation in a Pig Model of Sleep Apnea. J Cardiovasc Electrophysiol. 2016 Sep;27(9):1086-92. doi: 10. — View Citation

Linz D, Mahfoud F, Schotten U, Ukena C, Neuberger HR, Wirth K, Böhm M. Effects of electrical stimulation of carotid baroreflex and renal denervation on atrial electrophysiology. J Cardiovasc Electrophysiol. 2013 Sep;24(9):1028-33. doi: 10.1111/jce.12171. — View Citation

Oliveira M. Comment on "Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction". Rev Port Cardiol. 2015 Dec;34(12):795-7. — View Citation

Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: sa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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