Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction (NCT05637853) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Sweden60 participantsStarted 2022-10-22
Plain-language summary
Research hypothesis:
Fast telemonitored medical sequencing in patients with heart failure with reduced ejection fraction (HFrEF) is safe and feasible.
Background:
Modern therapy for HFrEF offers a highly effective arsenal of drugs, devices and interventional therapies, yet mortality and morbidity remain high in the cohort. One major problem is that drug therapy introduction and up titration has been very hard to implement in a majority of HFrEF patients. Most previous telemonitoring studies have focused on the continuous monitoring of patients and the monitoring itself has been the main intervention. A potentially more effective way to use telemonitoring in heart failure patients may be to combine the technique with a medical intervention when the patients are most vulnerable to heart failure events. The best therapeutic window lies in the period after newly diagnosed heart failure or right after a recent hospitalization following worsened chronic HFrEF.
Method:
We aim to use telemonitoring for fast sequencing of heart failure drugs for patients with HFrEF.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with HFrEF and without contraindications for either of the following drug classes: SGLT2i, BB, RAASi and MRA.
Exclusion Criteria:
* Estimated glomerular filtration rate (eGFR)\<45 ml/min Patients with HFrEF already on treatment with either BB or ACEi/ARNI/ARB and up titrated to \>50% of maximal recommended dose.
Patients who do not have access to a smartphone or internet connection at home. Patients not able to comprehend the technical aspects of home monitoring or unable to give informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients