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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06678841




Registration number
NCT06678841
Ethics application status
Date submitted
14/10/2024
Date registered
7/11/2024
Date last updated
28/08/2025

Titles & IDs
Public title
ELEVATE-HFpEF Clinical Study
Scientific title
Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)
Secondary ID [1] 0 0
MDT23039
Universal Trial Number (UTN)
Trial acronym
ELEVATE-HFpEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Preserved Ejection Fraction (HFpEF) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Personalized cardiac pacing

Experimental: Personalized Pacing Therapy (Treatment Group) - The treatment group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide dual chamber pacing at a personalized cardiac pacing rate determined by patient height and baseline LVEF percentage.

No intervention: Control Group - The control group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide ventricular pacing at a lower rate of 30 bpm. This is considered limited or backup pacing.


Treatment: Devices: Personalized cardiac pacing
Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP.
Timepoint [1] 0 0
Follow-up duration for endpoint analysis is 12-months.
Primary outcome [2] 0 0
Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.
Timepoint [2] 0 0
12-months post pacemaker implant attempt.
Secondary outcome [1] 0 0
Secondary Objective #1: Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups.
Timepoint [1] 0 0
Follow-up duration for endpoint analysis is 12-months.
Secondary outcome [2] 0 0
Secondary Objective #2: Compare the change in NT-proBNP from baseline to 12-months between randomized groups by comparing NT-proBNP measured at baseline and 12-months.
Timepoint [2] 0 0
Follow-up duration for endpoint analysis is 12-months.
Secondary outcome [3] 0 0
Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.
Timepoint [3] 0 0
Follow-up duration for endpoint analysis is 12-months.
Secondary outcome [4] 0 0
Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.
Timepoint [4] 0 0
Follow-up duration for endpoint analysis is 12-months.
Secondary outcome [5] 0 0
Secondary Objective #5: Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period.
Timepoint [5] 0 0
Follow-up duration for endpoint analysis is 12-months.

Eligibility
Key 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).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2029
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dawn Dyer
Address 0 0
Country 0 0
Phone 0 0
954-682-8334
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06678841