Remote monitoring for heart failure patients
Individually Tailored Remote Monitoring at Home After Hospitalisation for HEART Failure in Multi-morbid Patients (IT-HEART): a Randomised Clinical Trial
NA · Vestre Viken Hospital Trust · NCT05447598
This study tests a new remote monitoring program led by nurses for people with heart failure to see if it helps them get better follow-up care after leaving the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust (other) |
| Locations | 3 sites (Tønsberg, Vestfold And Telemark County and 2 other locations) |
| Trial ID | NCT05447598 on ClinicalTrials.gov |
What this trial studies
This study evaluates a nurse-led remote monitoring program for patients with acute heart failure to improve follow-up care after hospital discharge. By utilizing telecommunication technologies, the program aims to monitor patient status from a distance, facilitating timely access to care and promoting self-care behaviors. The study addresses the challenges of limited outpatient capacity and aims to enhance patient outcomes through early detection of cardiac decompensation. Participants will be compared to those receiving usual care treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a recent diagnosis of acute heart failure and symptoms of decompensation.
Not a fit: Patients with conditions that may pose significant risks or those with a short life expectancy due to non-cardiac causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and outcomes of heart failure patients post-discharge.
How similar studies have performed: While there have been conflicting results in previous studies on remote monitoring for heart failure, this approach is still considered promising and may offer new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 years * Known HF diagnosis (ICD-10: I50) recorded in hospital medical records * Admitted to hospital within 7 days before screening for acute HF with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening * Sign informed consent and expected to participate according to ICH / GCP Exclusion Criteria: * Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical * Not able to understand Norwegian language * Short life expectancy (\<6 months) due to non-cardiac causes
Where this trial is running
Tønsberg, Vestfold And Telemark County and 2 other locations
- Vestfold Hospital Trust — Tønsberg, Vestfold And Telemark County, Norway (RECRUITING)
- Vestre Viken Trust Drammen hospital — Drammen, Viken County, Norway (RECRUITING)
- Akershus University Hospital — Lørenskog, Norway (RECRUITING)
Study contacts
- Study coordinator: John Munkhaugen, MD,PhD
- Email: johmun@vestreviken.no
- Phone: +47 97524194
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.
Conditions: Heart Failure Acute, Remote Monitoring, Nurse's Role