Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection Fraction

Criteria the registry did not label

• Participants eligible for inclusion in this study must meet all of the following criteria:
• Voluntary written informed consent of the participant has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Heart failure with preserved ejection fraction, defined as one of the below criteria:
  • EF \>= 45% and HFA-PEFF score \>= 5 (Heart Failure Association-Pre-test assessment, Echocardiography and natriuretic peptide, Functional testing, Final etiology; heart failure association of the European Society of Cardiology and the Heart Failure Association (34))
  • EF \>= 45% and H2FPEF score \>= 6 (Heavy, Hypertensive, Atrial fibrillation, Pulmonary hypertension, Elder, Filling pressure; Mayo Clinic group (35)))
  • EF \>= 45% and
  • History of heart failure hospitalization after pacemaker implantation or ii.On loop-diuretics at time of inclusion
• Having a DDD-pacemaker with LBB area pacing, implanted at least 12 weeks before iCPET
• \>=6 weeks on optimal HFpEF therapy (MRA and SGLT2i) at time of iCPET, unless contraindicated or not tolerated
• Sinus rhythm at time of screening and iCPET
  • Participants eligible for this Study must not meet any of the following criteria:
• Participant has a history of:
  • Evidence of significant pulmonary comorbidity based on abnormal pulmonary function tests (FEV1 \<60%) or aberrant lung parenchyma more than mild on radiological imaging
  • Severe/symptomatic valvular diseases
  • Severe pulmonary hypertension (PASP \> 55mmHg estimated by Doppler Echo)
  • Unstable arrhythmias (VT, VF)
  • Recurrent syncopes after pacemaker implantation
  • Permanent atrial fibrillation
  • Amyloid cardiomyopathy
• Physical inability to perform exercise
• More than 1 hospitalization for heart failure in the last year
• Resting heart rate\> 100bpm
• At time of iCPET or inclusion: decompensated heart failure, unstable coronary syndrome
• Contraindication to central venous access
  • Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL)
  • Local infection or skin infection at the insertion site
  • Thrombosis or anatomical abnormalities of the right jugular vein
  • Pneumothorax or contralateral lung pathology
  • Inability to properly position the patient
• Contraindication to arterial access
  • Thrombosis or occlusion of the target artery
  • Raynaud's phenomenon or other vasospastic disorders
  • Active infection at the intended insertion site
  • Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL)
  • Insufficient collateral circulation (e.g., inadequate perfusion in an Allen test)
• Contraindications to CPET
  • ECG signifying myocardial injury
  • ECG signifying current or potentially lethal arrhythmias
  • Systemic hypotension (e.g. systolic blood pressure \< 90 mmHg)
  • Extreme hypertension (e.g. systolic blood pressure \> 220 mmHg)
  • Syncope, presyncope, or lightheadedness
  • SaO2 \< 88%
  • Severely elevated PCWP (\> 40 mmHg) during exercise