We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction (TELE-FASTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05637853
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Göteborg University

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.


Condition or disease
Heart Failure With Reduced Ejection Fraction

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Actual Study Start Date : October 22, 2022
Estimated Primary Completion Date : August 22, 2024
Estimated Study Completion Date : October 22, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

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.




Primary Outcome Measures :
  1. Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients [ Time Frame: 180 days ]
    Incidence of treatment-emergent adverse events up to 180 days from start of sequencing.


Secondary Outcome Measures :
  1. Proportion of patients reaching full doses of heart failure drugs with home -monitoring [ Time Frame: 8 weeks ]
    Proportion of patients reaching full doses of BB, SGLT2i, RAASi and MRA within 8 weeks

  2. Proportion of patients capable of reaching full doses of heart failure drugs compared to standard of care. [ Time Frame: 12 weeks ]
    Proportion of patients capable of reaching full doses of BB, SGLT2i, RAASi and MRA compared to reported prescriptions from Riks-Svikt (Swedish Heart Failure registry-Swede-heart failure).

  3. Proportion of patients still on OMT in future follow-up [ Time Frame: 5 years ]
    Proportion of patients still on OMT after 1, 3 and 5 years follow-up compared to prescription patterns from Riks-Svikt


Biospecimen Retention:   Samples Without DNA
Repeeted blood samples during sequencing


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with confirmed HFrEF within the last 3 months or hostitalized for worsening HFrEF will be screened for eligibility.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637853


Contacts
Layout table for location contacts
Contact: Tomas Mellberg, MD, PhD +46313421000 tomas.mellberg@vgregion.se
Contact: Niklas Bergh, MD, PhD +46313421000 niklas.bergh@vgregion.se

Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Tomas Mellberg, MD, PhD         
Sponsors and Collaborators
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Tomas Mellberg, MD, PhD Sahlgrenska University Hospital, Sweden
Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT05637853    
Other Study ID Numbers: TELE-FASTER-HF
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Home-monitoring
Medical sequencing
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases