Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825417
Status:
RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-03-24
Brief Title:
Pulmonary Hypertension Intensification and Personalisation of Combination Rx
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension PAH Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices CardioMEMSConfirmRx
Status:
RECRUITING
Status Verified Date:
2023-08
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:
PHoenix
Brief Summary:
The goal of this clinical trial is to evaluate the capacity of implantableremote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension PAH The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology activity and patient reported quality-of-life QoL outcomes Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans
Detailed Description:
In this study patients established on guideline recommended therapy will be implanted with devices and remote monitoring established Patients will then enter into a 2x2 crossover study of approved drugs during which standard clinical investigations will be undertaken at baseline and maximal therapy on each drug The cross-over design will provide multiple increases and decreases of drugs known to alter haemodynamics and 6MWT The study is powered to detect improvement in right ventricular stroke volume measured by MRI from baseline to maximal therapy for each drug It will then be established if changes in remote monitored measures provide an early indication of clinical efficacy when compared to the MRI haemodynamics NTproBNP and 6MWT made at 12-weeks Remote measurement of haemodynamics during the two periods of de-escalation will inform understanding of physiology and inform clinical practice The comparison of the two therapeutic strategies in individual patients in one study will facilitate novel clinical study designs and provide evidence for data-driven personalised medicine in the area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 325120 | OTHER | IRAS | None |
| MRW0262791 | OTHER_GRANT | None | None |