Heart failure with preserved ejection fraction Heart failure with preserved ejection fraction
Conditions
Interventions
This trial involves several steps, which are summarized below. All participants will undergo temporary AAI-pacing through femoral venous access with simultaneous PCWP measurement, to identify particip
Summary of different steps:1. Temporary AAI-pacing with PCWP measurement to identify participants in whom PCWP does not increase as a result to accelerated pacing.2. If no increase in PCWP is observed
3. Following pacemaker implantation, participants will undergo (AV-sequential) pacing while hemodynamic measurements (including PCWP, cardiac output, and arterial systemic blood pressure) are obtained
4. Subsequently, the pacemaker will remain to a pacing off mode for a recovery period of 45 days.5. Participants will then undergo 90 days of accelerated AV-sequential pacing to achieve an accelerated
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria:Adults > 18 years of age Diagnosis of HFpEF according to the ESC guidelines New York Heart Association (NHYA) class II or higher Resting HR < 80 bpm based on ECG’s or mean <70 bpm on Holter-monitoringParticipant is expected to remain available for follow-up visits No cardiac medication changes in the past 30-days (Beta-blocker use is acceptable)Clinically stable for at least 2 months prior to inclusionAble to provide written consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Intrinsic QRS duration > 150msPermanent Atrial FibrillationPreexisting pacemaker systems or implantable cardioverter-defibrillator (ICD)Hypertrophic obstructive cardiomyopathyInfiltrative or constrictive cardiomyopathy (cardiac amyloidosis/sarcoidosis/ constrictive pericarditis)More than moderate valvular stenosis or regurgitationAortic or mitral valve replacement untreated factors explaining symptoms (anemia, pulmonary disease) COPD Gold IV or pulmonary disease on home oxygenUncontrolled hypertension Patient participating in another interventional clinical trialLife expectancy < 1 yearNot being able to perform a representative 6MWT duo to non-cardiac causes (musculoskeletal- or neuromuscular- or neurodegenerative diseases)Myocardial infarction (MI) / Transient Ischemic Attack (TIA) / Cerebro Vascular Accident (CVA) < 3 monthsInterventricular septum thickness > 2 cm eGFR <25 ml/min/1.73m2Severe allergic reactions to contrast fluidHistory of reduced (LVEF<40%) ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in PCWP during a predefined pacing protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| The acute hemodynamic effects of accelerated pacing on:Systemic arterial blood pressureCardiac output (CO)The long-term (90-days) effects of accelerated pacing on:HRQoL, based on MLHFQNT-proBNP levels6MWT performanceDevice-detected AF-burdenDevice-detected daily activity | — |
Countries
Netherlands
Contacts
Public ContactJ Koll
Universiteit Maastricht
Outcome results
None listed