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ELEVATE-HFpEF Clinical Study

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

NCT ID: NCT06678841

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Personalized cardiac pacing (device)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Personalized cardiac pacing — device: Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Medtronic Cardiac Rhythm and Heart Failure, is looking at people aged 40 or over with a type of heart failure where the heart's pumping squeeze is normal but the heart is still stiff (called HFpEF, or heart failure with preserved ejection fraction). The study involves the heart's natural rate compared with a personalised cardiac pacing rate.

Who can take part

  • Age 40 or over
  • Heart pumping measurement (ejection fraction) of 50% or more, recorded in the past 12 months
  • Heart failure defined in the study way - for example, a worsening heart failure episode or hospital visit in the past 12 months, OR breathlessness on exertion with at least one extra sign such as fluid on the lungs, raised NT-proBNP blood test, certain heart pressure or heart scan findings
  • On stable, guideline-recommended heart failure medicine for at least 30 days
  • Average heart rate on a baseline heart monitor at least 5 beats per minute lower than the study's calculated personalised pacing rate
  • Able and willing to follow the study plan, including walking independently at the start

Who may not be able to

  • Heart pumping that has improved or recovered from below 50%
  • Having, or being due to have, a pacemaker, defibrillator or cardiac resynchronisation device
  • Currently pregnant
  • Average heart rate under 50 beats per minute, or a slow heart rate causing symptoms
  • Heart attack, heart surgery or urgent heart procedures in the past 3 months, or a planned heart procedure in the past 30 days
  • Currently very unwell with heart failure needing intravenous drugs
  • Body mass index (BMI) over 45
  • Long-standing atrial fibrillation (an irregular heart rhythm) with a very slow heart rate or pauses
  • Planned atrial fibrillation ablation procedure
  • Certain heart muscle conditions such as amyloidosis, sarcoidosis or hypertrophic cardiomyopathy
  • Uncontrolled high blood pressure (above 160/100 mmHg)
  • Advanced kidney disease (stage 4 or worse)
  • More than moderate heart valve disease
  • Serious lung disease needing oxygen at home
  • Known reason why a pacemaker cannot be fitted
  • Other serious illness with life expectancy under 1 year
  • Currently in another drug or device trial (unless pre-approved by the Medtronic Study Manager)
  • A vulnerable adult who cannot give consent

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
700
Started
2025-07-09
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
  • • NA - 700 participants
  • • ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF)

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with heart failure with preserved ejection fraction (hfpef)

Where?

  • • Leeds - The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
  • • London - Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital
  • • Manchester - Manchester University NHS Foundation Trust - Manchester Royal Infirmary

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

More detail

This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group). Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.

Heart Failure With Preserved Ejection Fraction (HFpEF)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

for negative

What the study is looking for

  • ✓Age ≥ 40 years
  • ✓Documented EF ≥50% within the preceding 12 months
  • ✓HFpEF defined as:
  • ✓Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous...
  • ✓Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING...

Who cannot take part

  • ✗Improved or recovered EF (i.e., prior LVEF\<50%)
  • ✗Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
  • ✗Average heart rate \<50 bpm or causing symptoms bradycardia
  • ✗Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
  • ✗Severe obesity defined as BMI \>45.
See the full criteria
Inclusion Criteria: 1. Age ≥ 40 years 2. Documented EF ≥50% within the preceding 12 months 3. HFpEF defined as: 1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR 2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA: * Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure * Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs) * Echo criteria defined by ≥2 of: * LV wall thickness ≥ 12 mm * LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2 * Relative wall thickness ≥0.42 * E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \<7 cm/s or lateral e' \<10cm/s * Tricuspid regurgitation (TR) velocity \>2.8 m/s * Left atrial (LA) enlargement, defined by LA volume index \>34 ml/m2 4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days 5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible) 6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline). Exclusion Criteria: 1. Improved or recovered EF (i.e., prior LVEF\<50%) 2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)) 3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction) 4. Average heart rate \<50 bpm or symptomatic bradycardia 5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit. 6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs. 7. Severe obesity defined as BMI \>45. 8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds 9. Planned AF ablation 10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis) 11. Hypertrophic cardiomyopathies 12. Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart 13. End Stage Renal Disease (CKD 4 or greater) 14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease) 15. Significant primary pulmonary disease on home oxygen 16. Known contraindication for a pacemaker implant 17. Advanced co-morbidity with life expectancy \< 1 year 18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager. 19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).

Where Is This Study? (3 UK sites)

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds LS1 3EX, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital

London SE1 7EH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Manchester M13 9WL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

How to Get in Touch

Dawn Dyer

Sponsor contact

CONTACT

954-682-8334 dawn.dyer@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06