NCT04205513: Medly Titrate

Use of Telemonitoring to Facilitate Heart Failure Medication Titration

Status unknown NA Last updated 19 March 2024

What this trial tests

NA trial testing Medly in Heart Failure in 108 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
31 December 2022

31 December 2024

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	1 January 2019
Primary completion	31 December 2022
Estimated completion	31 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• Medly

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure (HF) is a common diagnosis with high prevalence, reduced life expectancy and a significant clinical and economic burden. Large-scale randomized controlled trials have demonstrated that combination drug therapy, optimized to maximal tolerated doses, improves clinical outcomes in HF patients. However, evidence suggests that in clinical practice many patients never achieve target doses.

Barriers to medication titration include provider and patient-related factors, as well as limited time and support facilities to enable regular monitoring. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support, alerting, and patient self-management.

The primary objective of this study is to evaluate the effectiveness and safety of the implementation of telemonitoring to facilitate HF medication titration. The secondary objective is to obtain a deeper understanding of the experience of clinicians and HF patients taking part in the remote titration program.

The study will be conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, in Toronto. It will be based on a mixed methods effectiveness-implementation hybrid design and incorporate process evaluations alongside assessment of clinical outcomes.

The effectiveness research component will be assessed via a 2-arm randomized controlled trial (RCT), which will enroll 108 patients in total. The RCT will compare a predefined remote titration management strategy, which will utilize data from a smartphone-based telemonitoring system, with a standard titration management strategy consisting of regular in-office visits, and assess the efficacy and safety of the telemonitoring system in facilitating titration.

The implementation research component will consist of a qualitative study based on semi-structured interviews with a purposive sample of clinicians and patients, and assess the factors that can positively impact the implementation and effectiveness of the intervention.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial.
   Artanian V, Ross HJ, Rac VE, O'Sullivan M, et al · · 2020 · cited 20× · PMID 33141094 · DOI 10.2196/21962
2. The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial.
   Brahmbhatt DH, Ross HJ, O'Sullivan M, Artanian V, et al · · 2024 · cited 18× · PMID 38569821 · DOI 10.1016/j.jchf.2024.02.008
3. Using an Electronic App to Promote Home-Based Self-Care in Older Patients With Heart Failure: Qualitative Study on Patient and Informal Caregiver Challenges.
   Wali S, Keshavjee K, Nguyen L, Mbuagbaw L, et al · · 2020 · cited 14× · PMID 33164901 · DOI 10.2196/15885
4. Experiences and Perceptions of Patients and Providers Participating in Remote Titration of Heart Failure Medication Facilitated by Telemonitoring: Qualitative Study.
   Artanian V, Ware P, Rac VE, Ross HJ, et al · · 2021 · cited 11× · PMID 34842546 · DOI 10.2196/28259
5. Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial.
   Artanian V, Rac VE, Ross HJ, Seto E. · · 2020 · cited 7× · PMID 33048057 · DOI 10.2196/19705
6. Carbon and Travel Cost Reduction From Remote Medication Titration for Advanced Heart Failure: A Secondary Analysis of a Randomized Controlled Trial.
   Elfassy MD, Runeckles K, Simms N, Anderson GM, et al · · 2025 · PMID 40744126 · DOI 10.1016/j.cjca.2025.07.026