RecruitingNAINTERVENTIONAL

ELEVATE-HFpEF Clinical Study

The ELEVATE-HFpEF study is investigating a new way to treat heart failure where the heart's pumping ability seems normal but still causes symptoms (HFpEF). Researchers are testing if a specially programmed pacemaker, which adjusts to each person's needs, can improve how patients feel. Half of the participants will receive this personalised pacemaker setting, while the other half will have a standard pacemaker setting that minimises interference with their heart's natural rhythm. This comparison will help determine if the personalised approach is safe and effective. The study involves having a pacemaker implanted and then regular check-ups over several years to track progress and see if symptoms improve.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Enrolment target

700

Start

09 Jul 2025

Estimated completion

01 Feb 2029

Heart Failure With Preserved Ejection Fraction (HFpEF)

What is this study about?

This study, called ELEVATE-HFpEF, is looking into new treatments for a type of heart failure known as Heart Failure with Preserved Ejection Fraction (HFpEF). In this condition, your heart can still pump blood out to your body, but it struggles to relax properly and fill with blood. This can lead to symptoms like breathlessness and tiredness, even with everyday activities.

The researchers want to see if a specially programmed heart pacemaker can help. A pacemaker is a small device implanted under the skin that sends electrical pulses to the heart to help it beat in a more regular way. In this study, they're exploring if setting the pacemaker to a "personalised" rate, tailored to your body and heart, can improve your health and relieve your symptoms. They aim to find out if this approach is both safe and effective compared to a standard pacemaker setting.

It's important to understand that this is a research study. The goal is to gather reliable information that could potentially help many people with HFpEF in the future. By comparing two different pacemaker settings, the researchers can determine if this personalised treatment offers a significant benefit.

Key takeaways

Investigating a new pacemaker approach for Heart Failure with Preserved Ejection Fraction (HFpEF).
Compares a personalised pacemaker setting to a standard, minimal setting.
Involves pacemaker implantation and regular follow-up over several years.
Aims to improve symptoms and quality of life for people with HFpEF.
Participation includes random assignment to one of two treatment groups.
Your ongoing medical care will not be affected if you choose to leave the study.

Who may be eligible?

To join this study, you generally need to be at least 40 years old. You must have been diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF), meaning your heart's main pumping chamber still works well, but you have symptoms or signs of heart failure. This might include having been hospitalised for heart failure or having shortness of breath during activity.

There are also specific medical criteria, such as certain measurements from heart scans or blood tests, that your doctor will check to confirm if you have HFpEF. You should also be taking standard medications for heart failure as prescribed by your doctor for at least a month.

Finally, your current heart rate needs to be lower than the personalised rate the pacemaker would be set to. You also need to be able to attend all study appointments and be willing to follow the study plan. Your study doctor and nurse will carefully review all these points with you to see if this study is a good fit.

Quick self-check

Are you 40 years old or older?
Have you been diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF)?
Have you been on regular heart failure medication for at least 30 days?
Are you willing and able to attend all study appointments over several years?
Is your average heart rate currently lower than the possible personalised pacemaker rate?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have some initial checks to ensure you meet all the study requirements. Then, you'll have a pacemaker implanted, which is a common procedure. Before you leave the hospital, you'll be assigned to one of two groups: either the group receiving the personalised pacemaker setting or the group receiving a standard, minimal pacing setting. This will be decided randomly, like flipping a coin.

You'll have follow-up visits at 2, 6, and 12 months after the pacemaker is implanted. At the 12-month visit, if you were in the standard pacing group, your pacemaker will then be programmed to the personalised setting. After this, all participants will continue with further visits at 14, 18, and 24 months. Following the 24-month mark, you'll have yearly check-ups until the study concludes, which is estimated to be about 4.5 years from the start.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the personalised pacemaker setting if it proves to be effective in improving your heart failure symptoms and overall well-being. However, there's no guarantee you will personally benefit, and you might experience side effects or complications associated with pacemaker implantation, as with any medical procedure. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

Banner - University Medical Center Phoenix
Phoenix, United States· Recruiting
Sutter Health Hospital
San Francisco, United States· Recruiting
Hartford Hospital
Hartford, United States· Recruiting
Cardiovascular Institute of Northwest Florida
Panama City, United States· Recruiting
Emory University
Atlanta, United States· Recruiting
The University of Chicago Medical Center
Chicago, United States· Recruiting
Norton Healthcare
Louisville, United States· Recruiting
Cardiovascular Institute of the South
Houma, United States· Recruiting
Tufts Medical Center
Boston, United States· Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, United States· Recruiting
Saint Lukes Mid America Heart Institute
Kansas City, United States· Recruiting
Duke University Medical Center
Durham, United States· Recruiting

+32 more sites — see the official record for the full list.

Common questions

What is HFpEF?

HFpEF is a type of heart failure where your heart muscle can still pump blood strongly, but it struggles to relax and fill properly with blood, leading to symptoms like breathlessness.

What is a pacemaker and how does it work?

A pacemaker is a small electronic device implanted under your skin that sends mild electrical signals to your heart to help it beat at a regular and healthy rhythm.

Will I know which treatment group I'm in?

No, in this study, neither you nor your doctors will know whether you are receiving the personalised pacemaker setting or the standard setting until after the first 12 months. This is to ensure the study results are as fair and unbiased as possible.

How long will I need to be involved in the study?

The study involves regular visits for about 2 years, followed by yearly check-ups until the study ends, which is estimated to be around 4.5 years in total.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without affecting your medical care.

How to find out more

Dawn Dyer

dawn.dyer@medtronic.com 954-682-8334 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.