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

Egyéb feltételek

• 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