Pacemaker Therapy for Heart Failure
(FIRE-HFpEF Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Must be taking: Heart failure medications
Disqualifiers: Atrial fibrillation, Structural heart disease, Severe COPD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
Will I have to stop taking my current medications?
The trial requires participants to be stable on their current heart failure medications for at least one month before joining, except for loop diuretics. This means you should continue taking your prescribed medications as directed by your doctor.
Is pacemaker therapy for heart failure safe for humans?
There is no specific safety data available for pacemaker therapy for heart failure in the provided research articles.
12345How is the Pacemaker PLR ON and Pacemaker PLR + TRT ON treatment for heart failure different from other treatments?
This treatment is unique because it involves a pacemaker that not only helps regulate heart rhythm but also includes features like cardiac resynchronization therapy (CRT), which can improve heart function in patients with heart failure by ensuring the heart's chambers beat in sync. This is particularly beneficial for patients with left ventricular dysfunction, a common issue in heart failure.
678910Eligibility Criteria
This trial is for people with heart failure who still have normal or near-normal heart pumping function (LVEF ≥ 55%), specifically those in NYHA Functional Class I-III without severe symptoms. Participants should show signs of a thickened heart muscle and be stable on standard heart failure meds, except diuretics, for at least a month. They can't join if they need a pacemaker for other reasons, have severe chest pain during exercise, permanent A-fib, recent valve surgery, serious lung disease like COPD, very low kidney function (eGFR < 25), uncontrolled high blood pressure despite treatment, or certain types of cardiomyopathy.Inclusion Criteria
My heart's size is within the normal range for my body size.
My heart's pumping ability is normal or above normal.
My heart condition allows me to perform daily activities with minimal to moderate difficulty.
+3 more
Exclusion Criteria
I experience chest pain when I exert myself.
I have severe lung disease such as advanced COPD.
I had an aortic valve replacement less than a year ago.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline and Implantation
Baseline data collection and pacemaker implantation
6 weeks
1 visit (in-person)
Randomization and Initial Follow-up
Randomization to pacing therapy or control, with follow-up visits at 3, 6, and 9 months
9 months
3 visits (in-person)
Therapy Modification
Therapy modifications based on initial randomization; pacing therapy terminated in original group and enabled in control group
3 months
1 visit (in-person)
Final Follow-up
Final follow-up visit with therapy cessation and exit from the study
3 months
1 visit (in-person)
Participant Groups
The FIRE-HFpEF study is testing whether special pacing therapies from pacemakers can improve the ability to exercise and overall health in patients with Heart Failure with Preserved Ejection Fraction (HFpEF). It's comparing two different pacemaker settings to see which might work better. Up to 105 participants will be randomly assigned to one of these treatments at multiple centers.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pacemaker with multiple pacing therapies enabledExperimental Treatment1 Intervention
Device will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).
Group II: Pacemaker with no pacing therapies enabledActive Control1 Intervention
Device will be programmed to a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AdventHealth CV Research InstituteOrlando, FL
Oklahoma Heart HospitalOklahoma City, OK
Duke UniversityDurham, NC
Dallas VA Medical CenterDallas, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
References
Routine Laboratory Parameter Dynamics and Laboratory Adverse Events in Psoriasis Patients on Long-term Treatment with Adalimumab, Etanercept, and Ustekinumab. [2017]Only limited data on laboratory parameter dynamics and safety under prolonged biologic treatment in a "real-world" scenario are available for recommendations on screening and monitoring. This study is a retrospective analysis of routine parameter dynamics and laboratory adverse events (LAE) in psoriasis patients on long-term treatment (n = 199) with tumour necrosis factor (TNF)-α-antagonists (adalimumab, etanercept), and the interleukin (IL)12/23-antagonist ustekinumab. Overall, neutrophil (PMN) counts (-11%) and triglycerides (+9%) changed considerably. TNF-α-antagonists and ustekinumab differentially affected lymphocyte counts (+13% and ±0%, respectively). Dynamics were pronounced during the first 180 days of treatment. In 340 treatment-years, 15 Common Terminology Criteria for Adverse Events (CTCAE) III-IV° LAE were recorded (11 involved liver enzymes). They prompted alteration of the biologic regime in only 2 cases. Age, sex, previous systemic treatments, and psoriatic arthritis did not significantly predict LAE. Liver enzyme and triglyceride screening may be warranted in some instances. Our data suggest that unguided monitoring of other routine laboratory parameters is unnecessary under long-term biologic treatment.
Laboratory monitoring of biologic therapies. [2017]The purpose of this report is to provide suggested guidance concerning the monitoring of TNF blocker therapy. Since the completion of randomized trials, several new long-term safety concerns have arisen, involving mycobacterial and opportunistic infections, cytopenias, lymphoma, demyelinating disease, drug-induced lupus, congestive heart failure and hepatotoxicity. Since these serious events are rare, widespread post-marketing use and prolonged follow-up have been required to analyze their prevalence. Monitoring of TNF inhibitors is necessary to reassure physicians and patients of the continued efficacy and safety of these drugs. No published recommendations on monitoring are available. The clinician must weigh the potential clinical benefits of TNF inhibition against potential adverse effects. Patients should be evaluated carefully for the risk or presence of infection, tuberculosis and other serious adverse events by regular visits, careful clinical assessments, and an assiduous, high index of suspicion for these rare events. Tuberculin skin testing using PPD is recommended before starting treatment with any TNF inhibitor.
Long-Term Outcome of the First Completely Leadless Cardiac Resynchronization Therapy in the United States. [2023]Completely leadless cardiac resynchronization therapy is feasible with the combination of Micra AV pacemaker (Medtronic Inc) and WiSE-CRT (EBR Inc) systems. Several reports have highlighted this combination in Europe. This case report presents a 1- year follow-up the first reported concomitant use of the leadless systems in the United States. (Level of Difficulty: Advanced.).
Clinical Trial and Registry Data. [2019]Physicians rely on safety and efficacy data from pivotal trials to guide treatment decisions and manage patients. Even with robust clinical trial data, there remain questions regarding rare safety events and generalizability. Registries complement clinical trials. By evaluating effectiveness and safety in broad patient populations and often providing longer term or larger numbers of patients or both compared to clinical trials, registries consolidate and may extend the safety observations derived from pivotal trials. Our review of phase 3 clinical trial data, long-term extension studies and biologics registries shows biologics to be a safe option for short- and long-term use. Tumor necrosis factor (TNF)-, interleukin (IL)-12/23- and IL-17-antagonists yield similar safety profiles regarding infections, malignancy and major adverse cardiovascular events. The known risk of tuberculosis activation with TNF agonists appears to be readily handled by screening. Mild to moderate candida infections and potential exacerbation or de novo onset of inflammatory bowel disease are associated with IL-17 blockade.
The implantation of AV leadless pacemaker - a case report. [2022]In early 2020 Food and Drug Administration (FDA) approved Micra AV - a new type of leadless pacemaker with atrioventricular synchrony, to treat patients with atrio-ventricular (AV) blocks. We describe one of the first in Poland case of a patient who was implanted with Micra AV pacemaker.
Outcomes in pacemaker-dependent patients upgraded from conventional pacemakers to cardiac resynchronization therapy-defibrillators. [2016]Pacemaker-dependent patients with left ventricular dysfunction benefit from upgrade to cardiac resynchronization therapy (CRT). Those at low risk for ventricular tachyarrhythmias may benefit similarly from upgrade to a CRT-defibrillator or CRT-pacemaker.
Cardiac resynchronization therapy in pacemaker-dependent patients with left ventricular dysfunction. [2021]Heart failure and left ventricular (LV) systolic dysfunction (LVSD) are common in patients with permanent pacemakers. The aim was to determine if cardiac resynchronization therapy (CRT) at the time of pulse generator replacement (PGR) is of benefit in patients with unavoidable RV pacing and LVSD.
Indications and recommendations for pacemaker therapy. [2007]Each year, pacemaker therapy is prescribed to approximately 900,000 persons worldwide. Current pacemaker devices treat bradyarrhythmias and tachyarrhythmias and, in some cases, are combined with implantable defibrillators. In older patients, devices that maintain synchrony between atria and ventricles are preferred because they maintain the increased contribution of atrial contraction to ventricular filling necessary in this age group. In general, rate-responsive devices are preferred because they more closely simulate the physiologic function of the sinus node. Permanent pacemakers are implanted in adults primarily for the treatment of sinus node dysfunction, acquired atrioventricular block, and certain fascicular blocks. They also are effective in the prevention and treatment of certain tachyarrhythmias and forms of neurocardiogenic syncope. Biventricular pacing (resynchronization therapy) recently has been shown to be an effective treatment for advanced heart failure in patients with major intraventricular conduction effects, predominately left bundle branch block. Many studies have documented that pacemaker therapy can reduce symptoms, improve quality of life and, in certain patient populations, improve survival.
Common questions about pacemakers. [2014]Pacemakers are indicated in patients with certain symptomatic bradyarrhythmias caused by sinus node dysfunction, and in those with frequent, prolonged sinus pauses. Patients with third-degree or complete atrioventricular (AV) block benefit from pacemaker placement, as do those with type II second-degree AV block because of the risk of progression to complete AV block. The use of pacemakers in patients with type I second-degree AV block is controversial. Patients with first-degree AV block generally should not receive a pacemaker except when the PR interval is significantly prolonged and the patient is symptomatic. Although some guidelines recommend pacemaker implantation for patients with hypersensitive carotid sinus syndrome, recent evidence has not shown benefit. Some older patients with severe neurocardiogenic syncope may benefit from pacemakers, but most patients with this disorder do not. Cardiac resynchronization therapy improves mortality rates and some other disease-specific measures in patients who have a QRS duration of 150 milliseconds or greater and New York Heart Association class III or IV heart failure. Patients with class II heart failure and a QRS of 150 milliseconds or greater also appear to benefit, but there is insufficient evidence to support the use of cardiac resynchronization therapy in patients with class I heart failure. Cardiac resynchronization therapy in patients with a QRS of 120 to 150 milliseconds does not reduce rates of hospitalization or death.
[Resynchronisation therapy in patients with heart failure: our results]. [2019]Resynchronisation therapy with biventricular permanent pacing stimulation is one method of treating patients with systolic heart failure, with echocardiograph signs of ventricular asynchrony and a prolonged QRS of longer than 120 milliseconds. This method has been accepted in most medical centres around the world and was instigated in our Pacemaker Centre in December 2001, 3 months after FDA approval for human use.