Prospective, open-label, single centre, observational study to evaluate the safety and
feasibility of using pulmonary artery pressure (PAP) monitors and wearable activity monitors
in patients with pulmonary hypertension (PH).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a prospective, open-label, observational study, to evaluate the safety and
feasibility of using pulmonary artery pressure monitors and wearable activity monitors in
patients with pulmonary hypertension. We plan to correlate data from the PAP monitors with
data from wearable activity monitors and review how often patients require ad hoc visits /
medication changes as well as review the optimum dose of drug achieved / patient QoL / risk
stratification and patient outcomes / mortality.
Suitable patients, with a confirmed diagnosis of PH on RHC, will be recruited from outpatient
clinic or day-case and ward admissions by physicians or the research team. A face to face or
telephone conversation will occur to discuss the study in detail and if the patient is
willing they will be given / sent a patient information sheet (PIS) and be invited to attend
a screening visit. If eligibility criteria are met, patients will complete a consent form and
have their medical history reviewed including but not limited to past medical history,
medication review, allergies and review of any hospital admissions in the previous 12 months.
A clinical examination with observations including, but not limited to blood pressure, heart
rate, oxygen saturations, respiratory rate, temperature, weight, height, body mass index
(BMI) and assessment of NYHA class will be undertaken. Patients will be asked to perform a
baseline six minute walk test, complete a quality of life questionnaire (EMPHASIS-10),
12-Lead ECG and baseline, clinically-indicated blood testing (including but not limited to
FBC,UE,LFT, clotting screen, NT-Pro BNP) and imaging performed in clinical practise (TTE or
cardiac MRI) will be reviewed. Eligible subjects will be scheduled for the Implant procedure.
Subjects on anticoagulation therapy (e.g. warfarin) may be instructed by the Investigator to
discontinue use 2 days prior to pressure sensor placement and may be bridged with low
molecular weight heparin if required according to local trust standard of care bridging
If eligible, patients will then attend for their implantation visit and at this point undergo
a RHC and a CardioMEMSTM sensor implant in the catheter laboratory. Baseline readings will be
taken from the pressure monitor (including systolic, mean and diastolic PAP and cardiac
output) and calibrated with readings taken at RHC. The patient's details will be uploaded to
the CardioMEMSTM HF system, enabling remote monitoring of their heart failure device. Time
will be spent educating and familiarising the patient with the home monitor system and
contact details given in case any issues arise on discharge. Patients will be advised to
submit one reading per day, preferably at the same time of day and in the same position i.e.
lying down flat or at 45 degrees etc. Patients will be asked to monitor their symptom burden
and to share this with the investigators.
The patient will also be given a Fitbit activity monitor and set up with an account that is
accessible to patient and physician to allowing activity to be monitored. The research team
will be able to continuously monitor data remotely from the CardioMEMSTM HF system and Fitbit
Patients will attend for follow-up visits at 30 days and 1 year and will have their history
reviewed and clinical examination and observations reassessed. At this point a repeat 6MWT,
emPHasis-10 questionnaire, NYHA functional class and 12 Lead ECG will be undertaken as well
as bloods testing and imaging as clinically indicated. Readings from the CardioMEMSTM HF
system and Fitbit platform will also be reviewed and compared to the patients symptom diary.
In between visits patients will be contacted by telephone and invited for unscheduled visits
if clinically indicated. Any clinically significant data or medication changes will be
discussed or fed back to the clinical PH team in charge of the patients routine care as
: CardioMEMS HF System
Eligible patients will be recruited and will attend for the implantation in line with standard of care procedures. The patient's details will be uploaded to the CardioMEMS HF system, enabling remote monitoring of their heart failure device. The patient will also be given a Fitbit activity monitor and set up with an account that is accessible to patient and physician to allowing activity to be monitored. The research team will be able to continuously monitor data remotely from the CardioMEMS HF system and Fitbit platform.
Device: - CardioMEMS HF System
The CardioMEMS HF System is the first and only FDA-approved wireless heart failure monitor. The system is a safe, reliable way to help your patients manage their heart failure.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU