Exercise Right Ventricular Coupling in HFpEF

NCT05731466 | Unknown FDA Device

• 1 other identifier: ENDURE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.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.
3. 3.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).

Conditions

Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Keywords

CardioMems; Exercise cardiovascular magnetic resonance; Heart Failure with Preserved Ejection Fraction; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Right ventricular-arterial coupling (RVAC)

  Whether baseline exercise RV-arterial coupling, determined by exercise CMR-CardioMems, can predict the development of progressive RV dysfunction after one year

  12 months

Secondary Outcomes (3)

• VO2max (mL/kg/min)

  12 months

• Right heart failure hospitalisation

  12 months

• SGLT-2

  12 months

Study Arms (1)

CardioMems (Clinical Indication)

OTHER

Single Arm, CardioMems implantation on clinical indication. No control group. Every participant is his/her own control (longitudinal follow-up)

Device: CardioMems HF System

Interventions

CardioMems HF System DEVICE

1. Implantation CardioMems device. 2. Evaluation of right ventricular-arterial coupling during exercise using a hybrid technique of real-time CMR-derived volume measures and CardioMems-derived pulmonary artery pressure measurements.

Also known as: CMR

CardioMems (Clinical Indication)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 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 study
• All participants need to be able to perform at least 40 watts on an upright bicycle stress test.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Abbott: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Guido Claessen, MD, PhD

CONTACT

+32 16 34 20 09; guido.claessen@uzleuven.be

Youri Bekhuis, MD

CONTACT

+32 16 34 66 56; youri.bekhuis@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor - Principal Investigator (MD. PhD)

Model Details: Prospective study

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 16, 2023
• Study Start: October 13, 2021
• Primary Completion: October 13, 2024
• Study Completion: December 31, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)