Impact of Telemonitoring on Heart Failure Management
Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
This study tests if using telemonitoring and remote check-ins can help people with high-risk heart failure use fewer healthcare resources and save money.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05653726 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether telemonitoring and telematic follow-up can reduce healthcare resource utilization and costs for patients with high-risk heart failure. Participants will be randomly assigned to either usual care or telematic care, which includes daily monitoring of vital signs and consultations with a specialized heart failure team. The study aims to evaluate the effectiveness and cost-efficiency of telematic follow-up in managing heart failure patients over a specified period.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with heart failure for at least three months who have experienced recent decompensation.
Not a fit: Patients with hemodynamic instability or those recently hospitalized for acute cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced healthcare costs and improved management of heart failure patients.
How similar studies have performed: Other studies have shown promising results with telemonitoring in chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months. * Admitted for decompensation of chronic HF. * Admitted for HF decompensation ≥30 days and ≤6 months. * HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose. * With previous optimized prognostic medical treatment. * Under treatment with loop diuretic drugs. * New York Heart Association functional class II, III or IV. Exclusion Criteria: * Inclusion in other intervention studies. * Hemodynamic instability. * Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days. * Uncontrolled arrhythmias * On waiting list for transplantation (any organ) or other cardiac surgery. * Advanced mechanical circulatory support. * Chronic renal disease on hemodialysis. * Life expectancy less than 1 year. * Moderate-severe cognitive impairment. * Manifest inability to use a technological system. * Institutionalized. * Limiting psychiatric pathology.
Where this trial is running
Madrid
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Carlos López-Azor García, MD, PhD
- Email: lopez.gcia.juan.carlos@gmail.com
- Phone: +34628026462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.