Exercise Measurement of Right Ventricular-arterial Coupling to Predict Hemodynamic Worsening in Heart Failure and Preserved Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Right ventricular-arterial coupling (RVAC)
Study Overview
Brief 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.
Detailed Description
In this prospective, two-center study, the investigators will recruit 30 HFpEF-PH patients in whom a CardioMEMS device will be implanted because of clinical indication. Potential study candidates will be enrolled in the outpatient clinic or during hospitalization.
Subjects who sign the informed consent form and meet the eligibility criteria at the baseline visit will be eligible for the trial. Subjects will undergo the study-related procedures, including clinical laboratory measurements and body mass index (BMI) calculation.
Eligible subjects will be scheduled for the Implant procedure (PA sensor implant in conjunction with a RHC procedure).
Subjects must also have an appropriately sized (≥7mm diameter) pulmonary artery branch identified by a selective pulmonary angiogram prior to Sensor implant. Subjects who do not meet this inclusion criteria will be documented as consented not implanted.
After implantation of the CardioMEMS device, the patient will be asked to perform cardiopulmonary exercise testing (CPET) with continuous expiratory gas monitoring on an upright cycle ergometer (ER900 and Alpha, Jaeger, Germany), using a continuous ramp protocol until exhaustion.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent obtained from subject
- •> 18 years of age
- •Diagnosis 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 visit
- •Presence 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 ≤
- •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 study
- •All participants need to be able to perform at least 40 watts on an upright bicycle stress test.
Exclusion Criteria
- •Subjects with an active infection
- •Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- •Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
- •Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
- •Subjects 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 dialysis
- •Subjects with congenital heart disease or mechanical heart valve(s)
- •Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
- •Subjects with known coagulation disorders
- •Subjects 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)
Outcomes
Primary Outcomes
Right ventricular-arterial coupling (RVAC)
Time Frame: 12 months
Whether baseline exercise RV-arterial coupling, determined by exercise CMR-CardioMems, can predict the development of progressive RV dysfunction after one year
Secondary Outcomes
- VO2max (mL/kg/min)(12 months)
- Right heart failure hospitalisation(12 months)
- SGLT-2(12 months)
Investigators
dr. Guido Claessen
Clinical Professor - Principal Investigator (MD. PhD)
Universitaire Ziekenhuizen KU Leuven