Actively Recruiting
Pulmonary Hypertension: Intensification and Personalisation of Combination Rx
Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2024-12-03
40
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
S
Sheffield Teaching Hospitals NHS Foundation Trust
Lead Sponsor
U
University of Glasgow
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the capacity of implantable/remote 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
CONDITIONS
Official Title
Pulmonary Hypertension: Intensification and Personalisation of Combination Rx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Age 18-80 years
- Diagnosed with PAH that is idiopathic, heritable, or associated with drugs, toxins, or connective tissue disease
- On a stable PAH therapy regime including any combination of ERA and PDE5i for at least 1 month prior to screening unless unable to tolerate therapy
- WHO functional class III
- Resting mean pulmonary artery pressure (mPAP) 520 mmHg, pulmonary capillary wedge pressure 415 mmHg, and pulmonary vascular resistance 52 Wood Units measured by right heart catheterisation at diagnosis
- Able to walk more than 50 meters in a 6-minute walk test at entry
- Estimated glomerular filtration rate (eGFR) greater than 30 ml/min/1.73 m2 at entry
- Clinically determined inadequate treatment response
You will not qualify if you...
- Unable to provide informed consent
- Pregnant
- History of unprovoked pulmonary embolism at any time
- Acute infection at time of screening (rescreening allowed)
- PAH due to HIV, portal hypertension, schistosomiasis, or congenital heart disease
- Pulmonary hypertension due to left heart, lung, thromboembolic, or unclear/multifactorial causes (Groups II-V)
- Unable to tolerate aspirin or P2Y12 inhibitors
- Hypersensitivity to selexipag or riociguat
- Clinically significant renal disease with eGFR �b430 ml/min/1.73 m2
- Anaemia with haemoglobin less than 10 g/dl
- Left-sided heart disease or significant cardiac disease including moderate or worse valve disease as specified
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sheffield Teaching Hospitals NHS FT
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
J
Jennifer Dick, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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