Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

NCT03230643 | Completed

• 1 other identifier: HDZ-KA_012_DG
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Barostim neo implantation DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients suffering from advanced heart failure with left ventricular ejection fraction of 35 % or less are eligible for this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Related Publications (10)

• 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.116.305268. Epub 2015 Mar 2.

  PMID: 25733594 RESULT

• 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 Aug;33(8):1704-8. doi: 10.1097/HJH.0000000000000603.

  PMID: 26132760 RESULT

• Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-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. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.

  PMID: 25982108 RESULT

• Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-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: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.

  PMID: 26011593 RESULT

• 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 severe heart failure. J Am Coll Cardiol. 2005 Nov 15;46(10):1875-82. doi: 10.1016/j.jacc.2005.06.081. Epub 2005 Oct 24.

  PMID: 16286175 RESULT

• 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. doi: 10.1016/j.repce.2015.12.014.

  PMID: 27099884 RESULT

• 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.

  PMID: 28181276 RESULT

• Linz D, Hohl M, Khoshkish S, Mahfoud F, Ukena C, Neuberger HR, Wirth K, Bohm 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: 10.1111/jce.13020. Epub 2016 Jun 22.

  PMID: 27235276 RESULT

• Linz D, Mahfoud F, Schotten U, Ukena C, Neuberger HR, Wirth K, Bohm 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. Epub 2013 May 2.

  PMID: 23638844 RESULT

• 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):2203-2212. doi: 10.1016/j.hrthm.2016.08.021. Epub 2016 Aug 9.

  PMID: 27520541 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: October 15, 2019
• Study Completion: May 31, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)