Use of Telemonitoring to Facilitate Heart Failure Medication Titration

NCT04205513 | Active Not Recruiting

• 2 other identifiers: 18-5351.0RGPIN-2014-04486
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Telemonitoring; Titration; Remote monitoring

Outcome Measures

Primary Outcomes (2)

• The proportion of patients achieving GDMT titration completion

  The proportion of patients achieving GDMT titration completion at 6 months. (Revised primary outcome, after internal pilot, therefore, 0.025 significance value to be used.)

  6 months from enrolment

• The number of clinic visits required to achieve GDMT titration completion

  The number of clinic visits (either in-person or virtually) required to achieve GDMT titration completion

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Median time to GDMT titration completion

  Through study completion, an average of 1 year

• Patient health outcomes (LVEF)

  Through study completion, an average of 1 year

• Patient health outcomes (BNP - Brain natriuretic peptide) levels

  Through study completion, an average of 1 year

• Patient health outcomes (Clinical)

  Through study completion, an average of 1 year

• Implementation barriers

  Through study completion, an average of 1 year

Study Arms (2)

Control Group

NO INTERVENTION

Standard titration management strategy, consisting of regular in-office visits.

Study Group

EXPERIMENTAL

Remote titration management strategy, consisting of telephone contacts, which will utilize data from the Medly system.

Device: Medly

Interventions

Medly DEVICE

Medly is a mobile phone-based telemonitoring system that enables patients with heart failure to take clinically relevant physiological measurements with wireless home medical devices and answer symptom questions on the mobile phone. The measurements are automatically and wirelessly transmitted to the mobile phone and then to a data server.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able to provide informed consent to participate in the program.
• Adult patients (age 18 years or older)
• Diagnosed with HF and followed by a cardiologist at the PMCC Heart Function Clinic, who has primary responsibility for management of the patient's HF.
• New York Heart Association (NYHA) Class II-III.
• Left ventricular ejection fraction (LVEF) 40% or less, based on echocardiography, determined within 3 months prior to randomization.
• Stable HF defined as no hospitalization within 3 months.
• Patient is not yet at target doses of guideline directed medical therapy (ACE inhibitor, and/or angiotensin receptor blocker, and/or b-blocker, and/or mineralocorticoid receptor antagonist at sub-optimal doses), and hence qualifies for up-titration. At the physician's estimate, the patient will require a minimum of about 2 months to achieve target doses of all HF medications
• Patient or their informal caregiver speaks and reads English adequately to participate in the program and understand the alerts/prompts in the Medly application.
• Ability to comply with using Medly (e.g., able to stand on the weight scale, able to answer symptom questions, etc.).
• Physicians at the clinics will ultimately determine which patients they believe may benefit from participating in the Medly Titrate Program. For these patients, the Titrate program will be offered in addition to their usual care at the UHN, which includes Medly telemonitoring.

You may not qualify if:

• Patients will be excluded from the study based on the clinical judgment of their healthcare provider. In addition, the following criteria will exclude patients from participation in the Medly Titrate Program:
• Active acutely decompensated heart failure.
• Already on target doses of guideline-directed medical therapy (GDMT).
• Inability to titrate medications due to adverse events including:
• History of angioedema
• Uncontrolled hypertension
• Hypotension preventing up-titration
• Heart rate at rest \<56 beats per minute
• Congenital heart disease.
• Previous heart transplant or currently awaiting heart transplant.
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within 6 weeks prior to randomization.
• Obstructive or restrictive cardiomyopathy.
• Second or third degree atrioventricular block without a pacemaker.
• Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation.
• Presence of other hemodynamically significant obstructive lesions of the LV outflow tract, including aortic and subaortic stenosis.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (5)

• Artanian V, Rac VE, Ross HJ, Seto E. 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. JMIR Res Protoc. 2020 Oct 13;9(10):e19705. doi: 10.2196/19705.

  PMID: 33048057 BACKGROUND

• Artanian V, Ross HJ, Rac VE, O'Sullivan M, Brahmbhatt DH, Seto E. 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. JMIR Cardio. 2020 Nov 3;4(1):e21962. doi: 10.2196/21962.

  PMID: 33141094 BACKGROUND

• Elfassy MD, Runeckles K, Simms N, Anderson GM, Simard A, Brahmbhatt DH, Seto E, Lipscombe A, Faroutan F, Miller FA, Ross HJ; Medly Titrate Study Team. Carbon and Travel Cost Reduction From Remote Medication Titration for Advanced Heart Failure: A Secondary Analysis of a Randomized Controlled Trial. Can J Cardiol. 2025 Dec;41(12):2451-2459. doi: 10.1016/j.cjca.2025.07.026. Epub 2025 Jul 29.

  PMID: 40744126 DERIVED

• Brahmbhatt DH, Ross HJ, O'Sullivan M, Artanian V, Mueller B, Runeckles K, Steve Fan CP, Rac VE, Seto E; Medly Titrate Study Team. The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial. JACC Heart Fail. 2024 Apr;12(4):678-690. doi: 10.1016/j.jchf.2024.02.008.

  PMID: 38569821 DERIVED

• Artanian V, Ware P, Rac VE, Ross HJ, Seto E. Experiences and Perceptions of Patients and Providers Participating in Remote Titration of Heart Failure Medication Facilitated by Telemonitoring: Qualitative Study. JMIR Cardio. 2021 Nov 25;5(2):e28259. doi: 10.2196/28259.

  PMID: 34842546 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Emily Seto, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 19, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)