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Exercise Right Ventricular Coupling in HFpEF

NCT05731466 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-16

No results posted yet for this study

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. 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. 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. 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.

Conditions

Interventions

DEVICE

CardioMems HF System

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2024-10-13
Completion
2025-12-31
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731466 on ClinicalTrials.gov