Kansas City, KSNCT06678841Now EnrollingIRB Ready

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial in Kansas City, KS

Access cutting-edge heart failure with preserved ejection fraction (hfpef) treatment through this clinical trial at a research site in Kansas City. Study-provided care at no cost to qualified participants.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure

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Expert Care in Kansas City

Access heart failure with preserved ejection fraction (hfpef) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure with preserved ejection fraction (hfpef) treatment provided free

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Check if you qualify for this heart failure with preserved ejection fraction (hfpef) clinical trial in Kansas City, KS

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Why Participate?

  • No-Cost Study Care

  • Local to Kansas City

    Convenient for KS residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Kansas City site if eligible
  4. 4Begin participation

About This Heart Failure With Preserved Ejection Fraction (HFpEF) Study in Kansas City

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).

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Who Can Participate

Inclusion Criteria

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 diuretics) within 12-months prior to baseline visit OR
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
Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
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)
Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).

Exclusion Criteria

Improved or recovered EF (i.e., prior LVEF\<50%)
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))
Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
Average heart rate \<50 bpm or symptomatic bradycardia
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.
Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
Severe obesity defined as BMI \>45.
Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
Planned AF ablation
Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
Hypertrophic cardiomyopathies
Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
End Stage Renal Disease (CKD 4 or greater)
More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
Significant primary pulmonary disease on home oxygen
Known contraindication for a pacemaker implant
Advanced co-morbidity with life expectancy \< 1 year
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.
Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Kansas City?

Yes, this clinical trial (NCT06678841) has an active research site in Kansas City, KS that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Preserved Ejection Fraction (HFpEF) Treatment Options in Kansas City, KS

If you're searching for heart failure with preserved ejection fraction (hfpef) treatment options in Kansas City, KS, this clinical trial (NCT06678841) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Kansas City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with preserved ejection fraction (hfpef) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with preserved ejection fraction (hfpef) clinical trials near you to find additional studies recruiting in your area.

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