Active not recruitingNAINTERVENTIONAL

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

The NECTAR-HF study is exploring a new treatment for heart failure using a small, implanted device that stimulates a nerve in the neck called the right vagal nerve. This nerve stimulation is thought to help the heart work better. The study focuses on people with a specific type of heart failure where their heart's pumping ability is reduced. Researchers want to see if this treatment can improve how the heart functions, boost energy levels, and enhance overall quality of life over six months. They will also be closely monitoring the safety of the device and treatment for up to 18 months. It’s a way to investigate if this innovative approach could become a helpful option for future heart failure care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Boston Scientific Corporation

Enrolment target

118

Start

21 Sep 2011

Estimated completion

30 Jun 2026

Heart Failure Congestive Heart Failure

Results

Results from this study

Posted January 2020

Results have been published for this study.

Primary outcome

Change in Left Ventricular End-systolic Dimension (LVESD)

Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm. The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).

Full results on the registry

What is this study about?

Heart failure is a condition where the heart isn't pumping blood around the body as well as it should. This can make everyday activities difficult. The NECTAR-HF study is a research project looking at a new treatment approach called 'right vagal nerve stimulation' for people living with heart failure. The vagal nerve is a major nerve that runs from your brain to many important organs, including your heart. By gently stimulating this nerve with a small, implanted device, doctors hope to help the heart work more efficiently.

The main goal of this study is to understand if stimulating the vagal nerve can improve how well your heart pumps blood, how much energy you have for daily activities, and your general quality of life. The study will also carefully check that the device and this type of treatment are safe over a longer period. This is an exploratory study, meaning it's one of the first times this specific treatment method is being investigated for heart failure in this way.

Taking part in this study could help doctors learn more about heart failure and potentially discover new ways to treat it in the future. It's important to remember that this is a research study, and while the aims are hopeful, the results are not guaranteed. The information gathered from participants will be crucial in understanding if this treatment could be a valuable option for others with heart failure.

Key takeaways

Investigating a new device-based treatment for heart failure.
Aims to improve heart function, energy, and quality of life.
Involves a small implanted device that stimulates the vagal nerve.
Participation includes regular check-ups and follow-up for up to 18 months.
It's a research study to understand if this treatment could help future patients.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and be able to understand and agree to take part. You should have stable heart failure that causes some symptoms (classified as NYHA class II-III), with a heart pumping ability (ejection fraction) of 35% or less. Your heart specialist should also have put you on the best possible medication for your heart failure.

There are several reasons why someone might not be able to join the study. For example, if you've recently been hospitalised for heart failure or had a heart attack, stroke, or certain heart procedures in the last three months. Also, if your heart rhythm is constantly 'atrial fibrillation', or if you have certain other serious health conditions like severe valve disease, specific lung problems, or require kidney dialysis, you wouldn't be eligible. The study also cannot include individuals with certain types of diabetes or those already taking part in another clinical trial.

Essentially, the study is looking for adults with a specific type and stability of heart failure who are otherwise generally well enough to undergo a minor procedure and participate in all necessary appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have stable heart failure with symptoms (NYHA II-III) and reduced pumping ability?
Are you currently on the best possible medication for your heart failure?
Have you avoided hospitalisation for heart failure, heart attack, or stroke in the last 3 months?
Do not have certain other serious medical conditions like severe lung disease, kidney disease needing dialysis, or uncontrolled atrial fibrillation.

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in the NECTAR-HF study, it would involve a few key steps. First, you would have a small, minor operation to implant the tiny device that stimulates the vagal nerve. This is a common type of procedure. After the device is implanted, there will be a phase where your heart specialist adjusts (titrates) the device settings to find the best level of stimulation for you. This adjustment will continue for some time after this initial phase.

You would have regular check-ups at the hospital or clinic over a period of 6 months to monitor your heart health, assess your energy levels, and see how you are feeling generally. These appointments will include various tests, such as blood draws, to get a clear picture of how the treatment is affecting you. After the initial 6-month assessment period, your safety will continue to be monitored for a longer period, up to 18 months in total, through further follow-up appointments. Throughout the study, you would continue to take your prescribed heart failure medications.

Potential risks and benefits

Taking part in a research study like NECTAR-HF involves both potential benefits and potential risks. The main potential benefit is that the vagal nerve stimulation might improve your heart's function, increase your energy levels, and enhance your overall quality of life. However, as this is a new treatment being studied, there's no guarantee it will help everyone, and it might not improve your heart condition. Potential risks are generally associated with the device implantation procedure, such as infection or discomfort at the implant site, as well as potential side effects from nerve stimulation itself, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UCL Bruxelles
Verified postcode
Brussels, Belgium
Nemocnice Na Homolce
Verified postcode
Prague, Czechia
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
Verified postcode
Vandœuvre-lès-Nancy, France
CHRU de Lille - Hôpital Cardiologique
Verified postcode
Lille, France
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Verified postcode
Bernau bei Berlin, Germany
Universitätsmedizin Göttingen
Verified postcode
Göttingen, Germany
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany
Azienda Ospedaliera Niguarda Cà Granda
Verified postcode
Milan, Italy
A. O. Dei Colli - Monaldi
Verified postcode
Naples, Italy
Policlinico San Matteo
Verified postcode
Pavia, Italy
Catharina Ziekenhuis Eindhoven
Verified postcode
Eindhoven, Netherlands

Common questions

What is 'heart failure'?

Heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like tiredness or breathlessness.

What is 'vagal nerve stimulation'?

It's a treatment where a small device sends gentle electrical pulses to a nerve called the vagal nerve, which helps control heart function.

Will I still need my usual heart failure medications?

Yes, you would continue to take all your regular heart failure medications as prescribed by your doctor throughout the study.

How long will I be in the study?

You will be closely assessed for 6 months, with continued safety monitoring up to 18 months in total.

What if I change my mind about participating?

You can withdraw from the study at any time, for any reason, without affecting your standard medical care.