Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH) (FIT-PH)

Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension.

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).

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

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 protocol.

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 platform.

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 appropriate.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of PH at right heart catheterisation (RHC) and New York Heart Association (NYHA) class III, prior admission for treatment of heart failure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Monitors
Time Frame: Through study completion - 30/03/2024
To test the safety and feasibility of pressure monitoring and wearable activity monitors in patients with PH.
Through study completion - 30/03/2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Artery Pressure
Time Frame: Through study completion - 30/03/2024
To correlate Pulmonary Artery Pressure changes with outcome and activity data.
Through study completion - 30/03/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Hypertension

Clinical Trials on CardioMEMS HF System

3
Subscribe