Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05731466

Exercise Right Ventricular Coupling in HFpEF

Conditions: Heart Failure With Preserved Ejection Fraction, Pulmonary Hypertension

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: Belgium

Summary

The investigators aim to evaluate the feasibility and prognostic value of right ventricular-arterial coupling (RVAC) during exercise in patients with HFpEF-PH using a hybrid technique of real-time CMRderived volume measures and CardioMEMS-derived pulmonary artery pressure measurements.The investigators will determine:Whether exercise RV-arterial coupling at baseline (assessed using hybrid CMRCardioMEMS) predicts development or worsening of exercise RV-arterial uncoupling during follow-up in HFpEF-PH patients.If HFpEF-PH patients developing RV dysfunction have a particular PAP pattern as assessed remotely using the CardioMEMS system. The investigators will determine differential characteristics in CardioMEMS pressure patterns in those developing RV dysfunction versus those who do not develop RV dysfunction, both at rest and during exercise. Hence, HFpEF-PH patients developing RV dysfunction may harbor a plateau of pulmonary artery pressures (as a reflection of RV-arterial uncoupling) despite clinical worsening.Whether extraction of raw pressure data obtained by the CardioMEMS system is feasible and enables post-processing using machine learning methods (artificial intelligence) for deep phenotyping of patients (in addition to clinical evaluation of pressure waveforms).The investigators aim to evaluate the effect of SGLT-2 inhibitors on RV-arterial coupling in patients with HFpEF-PH. In case a patient is not using an SGLT-2 inhibitor, the investigators will prescribe this after baseline testing, since SGLT-2 inhibitors are clinically indicated in these patients.

Eligibility Criteria

Inclusion Criteria:Written informed consent obtained from subject> 18 years of ageDiagnosis of NYHA Class III Heart Failure with preserved ejection fraction defined as LVEF≥45%At least 1 heart failure related hospitalization or urgent outpatient visit within 12 months of baseline visitPresence of pulmonary hypertension defined as mPAP>25 mmHg at rest or mPAP/CO slope >3 mmHg/L/min during exercise during right heart catheterization or tricuspid regurgitation velocity of > 2.8 m/s assessed by transthoracic echocardiography (data must be taken within the last 6 months prior to implantation)Subjects with a BMI ≤ 35. Subjects with BMI >35 will require their chest circumference to be measured at the axillary level, if > 65 inches the patient will not be eligible for the study.Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)Subjects willing and able to comply with the follow-up requirements of the studyAll participants need to be able to perform at least 40 watts on an upright bicycle stress test.Exclusion Criteria:Subjects with an active infectionSubjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosisSubjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterizationSubjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline VisitSubjects with Cardiac Resynchronization Device (CRT) , pacemaker or Implantable Cardioverter Defibrillator (ICD)Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysisSubjects with congenital heart disease or mechanical heart valve(s)Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visitSubjects with known coagulation disordersSubjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).Subjects with history of coronary artery bypass surgery (CABG)Subjects with severe valvular disease (4/4)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05731466). StuddyBuddy aggregates publicly available trial information.