Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction

NCT05637853 | Active Not Recruiting Phase 4

• 2 other identifiers: TELE-FASTER-HF2020-02632 202201899-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Home-monitoring; Medical sequencing

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients

  Incidence of treatment-emergent adverse events up to 180 days from start of sequencing.

  180 days

Secondary Outcomes (3)

• Proportion of patients reaching full doses or OMT of heart failure drugs with home -monitoring

  8 weeks

• Proportion of patients still on full target dosage or OMT in future follow-up

  5 years

• Changes in levels of NTproBNP during home monitored sequencing

  180 days

Study Arms (1)

HFrEF patients (diagnosed within 3 months or hospitalized for worsening of HFrEF)

EXPERIMENTAL

Standardized sequencing of all for main HFrEF drugs: Betablockers, RAASi, SGLT2i, MRA. All patients will be started on an SGLT2i (Empagliflozin or Dapagliflozin) and a betablocker (Metoprolol, Bisoprolol or Carvedilol) right after study inclusion. In the second week, RAASi will be introduced with either angiotensin converting enzyme inhibitor (ACEi)(Ramipril or Enalapril) or angiotensin receptor neprilisyn inhibitor (ARNI)(Sacubitril/Valsartan). If the patient is intolerant to either of these, an angiotensin receptor blocker (ARB)(Candesartan, Losartan, Valsartan) will be introduced. During the following weeks, both BB and ACEi/ARNI/ARB will be up titrated every second week according to the sequencing algoritm. MRA (Spironolactone, Eplerenone) will be introduced and up titrated in week 3 and 7 respectively. If the patient is already on either BB or ACEi/ARNI/ARB/MRA they will continue with the previous prescription and dose until the titration scheme indicates uptitration.

Drug: GDMT

Interventions

GDMT DRUG

Predifined fast uptitration of GDMT for HFrEF with support of home monitoring.

HFrEF patients (diagnosed within 3 months or hospitalized for worsening of HFrEF)

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with HFrEF and without contraindications for either of the following drug classes: SGLT2i, BB, RAASi and MRA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Study Officials

• Tomas Mellberg, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 5, 2022
• Study Start: October 22, 2022
• Primary Completion: August 26, 2024
• Study Completion (Estimated): August 26, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

SE (1)