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Completed

NCT Number: NCT03230643

Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in left ventricular ejection fraction

    Time frame: measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation

  2. Change in Quality of life

    Time frame: assessed baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation

  3. Change in NYHA functional class ranking

    Time frame: measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation

  4. Chance in exercise capacity (distance walked in 6 min)

    Time frame: measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation

  5. Change in N-terminal pro-brain natriuretic peptide

    Time frame: measured baseline and during follow up visits 3, 6 and 12 months after inclusion or Baroreflex Activation Therapy device activation

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2017
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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