Evaluating new monitoring technology for patients with pulmonary hypertension
Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension.
This study is testing new monitoring devices to see if they can help people with pulmonary hypertension manage their condition better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT04078243 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and feasibility of using pulmonary artery pressure monitors and wearable activity monitors in patients diagnosed with pulmonary hypertension. The study will correlate data from these monitors to evaluate patient outcomes, including the frequency of medication changes, quality of life, and overall mortality. Eligible patients will undergo a thorough screening process, including medical history reviews and clinical examinations, to ensure they meet the inclusion criteria. The study will also involve baseline assessments such as a six-minute walk test and quality of life questionnaires.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of pulmonary hypertension.
Not a fit: Patients with active infections, recent major cardiovascular events, or specific exclusions such as known coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance monitoring and management strategies for patients with pulmonary hypertension, potentially improving their quality of life and clinical outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using wearable technology for monitoring chronic conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of pulmonary hypertension (Group I,II,III and IV) * Age 18 years * Estimated glomerular filtration rate (eGFR) \> 25 * Body mass index (BMI) \< 35 (or equivalent) * Pulmonary artery (PA) branch 7mm * Negative pregnancy test (If female of childbearing age) * Written, informed consent completed * Willingness of the patient to comply Exclusion Criteria: * Group IV PH * Active infection * Pulmonary embolus (PE) or deep vein thrombosis (DVT) * Major cardiovascular event within past 2 months * Cardiac resynchronisation therapy (CRT) device within past 3 months * Mechanical right heart valve * Known coagulation disorder * Known hypersensitivity to aspirin or clopidogrel.
Where this trial is running
Sheffield, South Yorkshire
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Alexander Rotherman
- Email: a.rothman@sheffield.ac.uk
- Phone: 0114 2509550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.