Table 3

Ongoing randomised clinical trials of remote monitoring devices in HF

Study titleDescription of interventionProjected enrolmentExpected completion datePrimary outcome
Use of Telemonitoring to Facilitate Heart Failure Medication Titration
(NCT04205513)		Assess clinically relevant physiological measurements with wireless home medical devices and symptom questions on the mobile phone.108 participantsJuly 2020The number of visits required to achieve target doses by 1 year.
Automated Hovering for Congestive Heart Failure Patients (EMPOWER)
(NCT02708654)		Electronic pill bottle for diuretic and a Bluetooth scale with engagement incentives, in which eligibility to win will be conditional on medication adherence and registering a weight measurement.566 participantsMarch 2021Hospital readmission rate at 12 months.
New Model of Care in Heart Failure (AMULET)
(NCT03476590)		Assess heart rate, blood pressure, thoracic fluid content and total body water using impedance cardiography and bioimpedance scale.600 participantsJune 2021Cardiovascular death and/or hospitalisation for worsening HF at 12 months.
Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial (HERMeS)
(NCT03663907)		Remote daily telemonitoring and remote follow-up audio/video conference.508 participantsAugust 2021Cardiovascular death or non-fatal HF events at 6 months.
Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring (HF-eVOLUTION)
(NCT04292275)		Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.120 participantsSeptember 2021Area under the curve will be calculated for a daily dose-related medication score, guideline-directed medical therapy at 6 months.
Efficacy, Safety and Cost of Remote Monitoring of Patients with Cardiac Resynchronization Therapy (ECOST-CRT)
(NCT03012490)		Remote notification of HF parameters, atrial arrhythmias and patient’s symptoms and signs.652 participantsApril 2022Composite criteria including death from any cause and hospitalisation for worsening HF at 27 months.
Daily Ambulatory Remote Monitoring System For Post-Discharge Management Of ADHF (DAVID-HF)
(NCT03072693)		Remotely collected physiological data obtained from home-based and wearable devices.876 participantsJuly 2022Composite of rehospitalisation for acute decompensated HF and/or mortality at 12 months.
Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application (ERICA-HF) (NCT04591964)Remote monitoring with a mobile application which will assess dyspnoea, position in bed, oedema, weight change, blood pressure and heart rate.300 participantsDecember 2023Number of hospitalisations at 12 months (secondary endpoint).
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (SELFIe-HF)
(NCT04441203)		CardioMEMS HF sensor to monitor pulmonary artery pressures.150 participantsJune 2024Cardiovascular death, HF hospitalisation, ED evaluation for HF, unplanned intravenous HF therapy in outpatient clinic.
Remote Monitoring Analytics in HF (LINK-HF2)
(NCT04502563)		Clinical parameters from a small wearable sensor.240 participantsOctober 2024Hospitalisation rate at 90 days.
Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF)
(NCT03237858)		Remote monitoring of S1 and S3 heart sounds, night-time heart rate, thoracic impedance and respiration from the HeartLogic feature of implanted CRT-D or ICD devices.2700 participantsJanuary 2025All-cause mortality and HF hospitalisation after 4 years.

  • Summary of clinical trials from ClinicalTrials.gov meeting the following criteria: (1) testing remote monitoring devices; (2) current or future enrolment planned; (3) randomised design; and (4) assessing clinical endpoints.

  • ADHF, acute decompensated heart failure; CRT-D, cardiac resynchronisation therapy; ED, emergency department; HF, heart failure; ICD, internal cardiac defibrillator.