Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2025-12-16 @ 5:35 PM
Study NCT ID:
NCT05731466
Status:
None
Last Update Posted:
2023-02-16 00:00:00
First Post:
2022-12-21 00:00:00
Brief Title:
Exercise Right Ventricular Coupling in HFpEF
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Exercise Measurement of Right Ventricular-arterial Coupling to Predict Hemodynamic Worsening in Heart Failure and Preserved Ejection Fraction
Status:
None
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDURE
Brief Summary:
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.
During the next visit, exercise RVAC will be assessed using a hybrid approach of exercise CMR and PAP measurement using the CardioMEMS system (Figure 1). Firstly, subjects will perform supine bicycle exercise within the CMR bore using a cycle-ergometer with adjustable electronic resistance (Lode, Groningen, The Netherlands). Exercise workloads for the exercise CMR protocol will be determined as 25%, 50% and 66% of peak power (Pmax) achieved during previous CPET, as the investigators previously demonstrated that supine exercise at 66% of peak power closely corresponds to maximal sustainable exercise intensity in an upright position. After the exercise test in the CMR bore, a second exercise test will be repeated on a supine bicycle ergometer. The CardioMEMS transmit-receive coil will be put under the back of the supine patient. After waiting one minute for the patient to stabilize, the CardioMEMS measurement will be initiated at rest and subsequently at the same workloads as during the exercise CMR protocol. This second exercise test will be combined with a exercise echocardiography.
CMR imaging will be performed on a Philips 1.5T CMR (Philips Medical Systems, Best, The Netherlands). RV-arterial coupling will be evaluated using a combined approach of CardioMEMS-derived pulmonary artery pressure data and CMR-derived volume data, thereby enabling the calculation of RV end-systolic pressure volume relationships. In addition, RVEF will be assessed as surrogate measure of RV-arterial coupling.
Prior to hospital discharge, subjects will be trained on the home monitoring system and instructed to take pulmonary artery pressure measurements daily at approximately the same time each day in the morning or as directed by their physician. Subjects will be supplied with a patient implant identification card, a Patient System Manual, and a Helpline phone number.
After discharge, the subject will take PA pressure measurements at home, as directed by the investigator, utilizing the CardioMEMS HF System. These measurements will be transmitted via modem to a secure data base. Patient compliance will be monitored by the Investigator.
Follow-up study visits will be scheduled at Month 1, Month 6, and every 6 months thereafter for 2 years (± 14 days visit window). Follow-up visits will include a physical exam, evaluation of NYHA Class, heart failure medications review, quality of life assessment, and assessment of any hospitalizations (including HF hospitalizations), that may have occurred between visits. In addition, all contacts between site staff and study subjects post implant will be recorded on a log to capture frequency, purpose and outcome of each contact.
The hybrid exercise CMR-CardioMEMS-derived assessment of exercise RVAC will be repeated at Month 6 and after 1 year following the same exercise protocol as detailed above.
All subjects included in this trial meet the criteria to start a SGLT-2 inhibitor on clinical indication following the latest evidence. Those who currently lack a SGLT-2 inhibitor, this medication will be initiated after the run-in period and the baseline testing (6 weeks after implantation of de CardioMems device).
Biochemistry will involve traditional parameters, such as hemoglobin, hematocrit, ionogram, renal function, NTproBNP, hs-troponin hs-CRP, ferritin, transferrin and iron level. In addition, at each time point, samples (serum and whole blood) will be stored for future analyses at Biobank UZ Leuven.
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.
During the next visit, exercise RVAC will be assessed using a hybrid approach of exercise CMR and PAP measurement using the CardioMEMS system (Figure 1). Firstly, subjects will perform supine bicycle exercise within the CMR bore using a cycle-ergometer with adjustable electronic resistance (Lode, Groningen, The Netherlands). Exercise workloads for the exercise CMR protocol will be determined as 25%, 50% and 66% of peak power (Pmax) achieved during previous CPET, as the investigators previously demonstrated that supine exercise at 66% of peak power closely corresponds to maximal sustainable exercise intensity in an upright position. After the exercise test in the CMR bore, a second exercise test will be repeated on a supine bicycle ergometer. The CardioMEMS transmit-receive coil will be put under the back of the supine patient. After waiting one minute for the patient to stabilize, the CardioMEMS measurement will be initiated at rest and subsequently at the same workloads as during the exercise CMR protocol. This second exercise test will be combined with a exercise echocardiography.
CMR imaging will be performed on a Philips 1.5T CMR (Philips Medical Systems, Best, The Netherlands). RV-arterial coupling will be evaluated using a combined approach of CardioMEMS-derived pulmonary artery pressure data and CMR-derived volume data, thereby enabling the calculation of RV end-systolic pressure volume relationships. In addition, RVEF will be assessed as surrogate measure of RV-arterial coupling.
Prior to hospital discharge, subjects will be trained on the home monitoring system and instructed to take pulmonary artery pressure measurements daily at approximately the same time each day in the morning or as directed by their physician. Subjects will be supplied with a patient implant identification card, a Patient System Manual, and a Helpline phone number.
After discharge, the subject will take PA pressure measurements at home, as directed by the investigator, utilizing the CardioMEMS HF System. These measurements will be transmitted via modem to a secure data base. Patient compliance will be monitored by the Investigator.
Follow-up study visits will be scheduled at Month 1, Month 6, and every 6 months thereafter for 2 years (± 14 days visit window). Follow-up visits will include a physical exam, evaluation of NYHA Class, heart failure medications review, quality of life assessment, and assessment of any hospitalizations (including HF hospitalizations), that may have occurred between visits. In addition, all contacts between site staff and study subjects post implant will be recorded on a log to capture frequency, purpose and outcome of each contact.
The hybrid exercise CMR-CardioMEMS-derived assessment of exercise RVAC will be repeated at Month 6 and after 1 year following the same exercise protocol as detailed above.
All subjects included in this trial meet the criteria to start a SGLT-2 inhibitor on clinical indication following the latest evidence. Those who currently lack a SGLT-2 inhibitor, this medication will be initiated after the run-in period and the baseline testing (6 weeks after implantation of de CardioMems device).
Biochemistry will involve traditional parameters, such as hemoglobin, hematocrit, ionogram, renal function, NTproBNP, hs-troponin hs-CRP, ferritin, transferrin and iron level. In addition, at each time point, samples (serum and whole blood) will be stored for future analyses at Biobank UZ Leuven.
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
During the next visit exercise RVAC will be assessed using a hybrid approach of exercise CMR and PAP measurement using the CardioMEMS system Figure 1 Firstly subjects will perform supine bicycle exercise within the CMR bore using a cycle-ergometer with adjustable electronic resistance Lode Groningen The Netherlands Exercise workloads for the exercise CMR protocol will be determined as 25 50 and 66 of peak power Pmax achieved during previous CPET as the investigators previously demonstrated that supine exercise at 66 of peak power closely corresponds to maximal sustainable exercise intensity in an upright position After the exercise test in the CMR bore a second exercise test will be repeated on a supine bicycle ergometer The CardioMEMS transmit-receive coil will be put under the back of the supine patient After waiting one minute for the patient to stabilize the CardioMEMS measurement will be initiated at rest and subsequently at the same workloads as during the exercise CMR protocol This second exercise test will be combined with a exercise echocardiography
CMR imaging will be performed on a Philips 15T CMR Philips Medical Systems Best The Netherlands RV-arterial coupling will be evaluated using a combined approach of CardioMEMS-derived pulmonary artery pressure data and CMR-derived volume data thereby enabling the calculation of RV end-systolic pressure volume relationships In addition RVEF will be assessed as surrogate measure of RV-arterial coupling
Prior to hospital discharge subjects will be trained on the home monitoring system and instructed to take pulmonary artery pressure measurements daily at approximately the same time each day in the morning or as directed by their physician Subjects will be supplied with a patient implant identification card a Patient System Manual and a Helpline phone number
After discharge the subject will take PA pressure measurements at home as directed by the investigator utilizing the CardioMEMS HF System These measurements will be transmitted via modem to a secure data base Patient compliance will be monitored by the Investigator
Follow-up study visits will be scheduled at Month 1 Month 6 and every 6 months thereafter for 2 years 14 days visit window Follow-up visits will include a physical exam evaluation of NYHA Class heart failure medications review quality of life assessment and assessment of any hospitalizations including HF hospitalizations that may have occurred between visits In addition all contacts between site staff and study subjects post implant will be recorded on a log to capture frequency purpose and outcome of each contact
The hybrid exercise CMR-CardioMEMS-derived assessment of exercise RVAC will be repeated at Month 6 and after 1 year following the same exercise protocol as detailed above
All subjects included in this trial meet the criteria to start a SGLT-2 inhibitor on clinical indication following the latest evidence Those who currently lack a SGLT-2 inhibitor this medication will be initiated after the run-in period and the baseline testing 6 weeks after implantation of de CardioMems device
Biochemistry will involve traditional parameters such as hemoglobin hematocrit ionogram renal function NTproBNP hs-troponin hs-CRP ferritin transferrin and iron level In addition at each time point samples serum and whole blood will be stored for future analyses at Biobank UZ Leuven
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
During the next visit exercise RVAC will be assessed using a hybrid approach of exercise CMR and PAP measurement using the CardioMEMS system Figure 1 Firstly subjects will perform supine bicycle exercise within the CMR bore using a cycle-ergometer with adjustable electronic resistance Lode Groningen The Netherlands Exercise workloads for the exercise CMR protocol will be determined as 25 50 and 66 of peak power Pmax achieved during previous CPET as the investigators previously demonstrated that supine exercise at 66 of peak power closely corresponds to maximal sustainable exercise intensity in an upright position After the exercise test in the CMR bore a second exercise test will be repeated on a supine bicycle ergometer The CardioMEMS transmit-receive coil will be put under the back of the supine patient After waiting one minute for the patient to stabilize the CardioMEMS measurement will be initiated at rest and subsequently at the same workloads as during the exercise CMR protocol This second exercise test will be combined with a exercise echocardiography
CMR imaging will be performed on a Philips 15T CMR Philips Medical Systems Best The Netherlands RV-arterial coupling will be evaluated using a combined approach of CardioMEMS-derived pulmonary artery pressure data and CMR-derived volume data thereby enabling the calculation of RV end-systolic pressure volume relationships In addition RVEF will be assessed as surrogate measure of RV-arterial coupling
Prior to hospital discharge subjects will be trained on the home monitoring system and instructed to take pulmonary artery pressure measurements daily at approximately the same time each day in the morning or as directed by their physician Subjects will be supplied with a patient implant identification card a Patient System Manual and a Helpline phone number
After discharge the subject will take PA pressure measurements at home as directed by the investigator utilizing the CardioMEMS HF System These measurements will be transmitted via modem to a secure data base Patient compliance will be monitored by the Investigator
Follow-up study visits will be scheduled at Month 1 Month 6 and every 6 months thereafter for 2 years 14 days visit window Follow-up visits will include a physical exam evaluation of NYHA Class heart failure medications review quality of life assessment and assessment of any hospitalizations including HF hospitalizations that may have occurred between visits In addition all contacts between site staff and study subjects post implant will be recorded on a log to capture frequency purpose and outcome of each contact
The hybrid exercise CMR-CardioMEMS-derived assessment of exercise RVAC will be repeated at Month 6 and after 1 year following the same exercise protocol as detailed above
All subjects included in this trial meet the criteria to start a SGLT-2 inhibitor on clinical indication following the latest evidence Those who currently lack a SGLT-2 inhibitor this medication will be initiated after the run-in period and the baseline testing 6 weeks after implantation of de CardioMems device
Biochemistry will involve traditional parameters such as hemoglobin hematocrit ionogram renal function NTproBNP hs-troponin hs-CRP ferritin transferrin and iron level In addition at each time point samples serum and whole blood will be stored for future analyses at Biobank UZ Leuven
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None