Evaluating exercise right ventricular coupling in heart failure patients
Exercise Measurement of Right Ventricular-arterial Coupling to Predict Hemodynamic Worsening in Heart Failure and Preserved Ejection Fraction
This study is testing if measuring how well the right side of the heart works with the arteries during exercise can help predict problems in heart failure patients with preserved ejection fraction and pulmonary hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05731466 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility and prognostic value of right ventricular-arterial coupling (RVAC) during exercise in patients with heart failure with preserved ejection fraction and pulmonary hypertension. Using a hybrid technique that combines real-time cardiovascular magnetic resonance (CMR) volume measures and CardioMEMS-derived pulmonary artery pressure measurements, the study will evaluate whether baseline exercise RVAC can predict worsening RV uncoupling over time. Additionally, it will investigate specific pulmonary artery pressure patterns in patients who develop RV dysfunction compared to those who do not. The study will involve 30 patients who will undergo a CardioMEMS device implantation and subsequent cardiopulmonary exercise testing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with NYHA Class III heart failure and pulmonary hypertension.
Not a fit: Patients with a BMI over 35 and those with inadequate pulmonary artery branch size for sensor implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients with heart failure and pulmonary hypertension.
How similar studies have performed: Other studies have shown promise in using similar hybrid approaches for monitoring heart failure, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent obtained from subject 2. \> 18 years of age 3. Diagnosis of NYHA Class III Heart Failure with preserved ejection fraction defined as LVEF≥45% 4. At least 1 heart failure related hospitalization or urgent outpatient visit within 12 months of baseline visit 5. 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) 6. 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. 7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC) 8. Subjects willing and able to comply with the follow-up requirements of the study 9. All participants need to be able to perform at least 40 watts on an upright bicycle stress test. Exclusion Criteria: 1. Subjects with an active infection 2. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis 3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization 4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit 5. Subjects with Cardiac Resynchronization Device (CRT) , pacemaker or Implantable Cardioverter Defibrillator (ICD) 6. 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 7. Subjects with congenital heart disease or mechanical heart valve(s) 8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit 9. Subjects with known coagulation disorders 10. 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). 11. Subjects with history of coronary artery bypass surgery (CABG) 12. Subjects with severe valvular disease (4/4)
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Guido Claessen, MD, PhD
- Email: guido.claessen@uzleuven.be
- Phone: +32 16 34 20 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.