Remote Monitoring After Heart Failure

NCT05447598 | Active Not Recruiting

• 1 other identifier: 464460
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Heart failure (HF) is a leading cause of hospitalisation and disability-adjusted life years lost, with mortality rates exceeding most cancers. Despite compelling evidence and recommendations, less than 20% of the HF patients are followed-up by the specialist healthcare after hospital discharge. Due to limited outpatient capacity, human resources and increasing incidence of HF over the next decades, new care models are obviously needed. Remote monitoring (i.e. telemonitoring) encompasses the use of audio, video and other telecommunication technologies to monitor patient status at a distance. Remote monitoring is a promising strategy that can facilitate rapid access to care when needed and reduce patient travel to hospital consultations. It also promotes self-care behaviour, psychosocial support, and early detection of cardiac decompensation. Despite intensive research for \>10 years, randomised trials show conflicting results, and European HF guidelines are confined to a weak (class IIb, level of evidence B) recommendation. More knowledge about the role of remote monitoring strategies in HF management, especially in the transition from hospital to home, is thus requested in the most recent European and US guidelines. In particular, studies of high-risk patients integrating the community health services are largely lacking. Furthermore, the components of the intervention that mediate the effect need to be identified. The proposed study aims to address these gaps in evidence and assess whether individually tailored remote monitoring at home (IT-HEART) is improves clinical outcomes in patients hospitalized with decompensated HF. We also aim to identify modifiable clinical and behavioural (drug adherence, self-care, psychological factors) outcome predictors. A prospective, multicentre, randomized, open-label, blinded endpoint adjudication (PROBE) intervention study is designed and powered to include at least 200 patients with at least one HF hospitalization in the 12 months preceding enrolment. To ensure generalizability, patients will be included regardless of comorbidity, frailty and ejection fraction. We have conducted a pilot-study providing empirical evidence for the expected participation rate, readmission rate and barriers to HF management in current clinical practice that will be targets for the intervention. This will promote high adherence to the intervention and positive long-term clinical and health economic effects.

Conditions

Heart Failure Acute; Remote Monitoring; Nurse's Role

Outcome Measures

Primary Outcomes (2)

• Rate of re-hospitalizations for heart failure

  Rate of re-hospitalizations for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms

  From time of randomization until 12 months follow-up

• Time to first re-hospitalization for heart failure

  Time to first re-hospitalization for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms

  From time of randomization until 12 months follow-up

Secondary Outcomes (7)

• Rate of total death

  From time of randomization until 12 months follow-up

• Rate of unplanned re-hospitalizations

  From time of randomization until 12 months follow-up

• Total number of days lost due to unplanned heart failure admissions treatment arms

  From time of randomization until 12 months follow-up

• Total number of days lost due to unplanned hospital admissions treatment arms

  From time of randomization until 12 months follow-up

• Changes in selfcare behaviour

  From baseline until three months follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Remote monitoring program

Other: Nurse-led remote monitoring program

Usual care

ACTIVE COMPARATOR

Current clinical pratice at the participating hospitals

Other: Usual care treatment

Interventions

Nurse-led remote monitoring program OTHER

Symptoms of disease progression, clinical parameters, medication adherence and follow-up needs will be reported by patients or with support from relatives or homecare nurses 2-4 times/months over a three months period using a digital platform. Telephone monitoring is planned for patients who are not able to comply with the digital platform. In addition, an individualized self-treatment plan for diuretics and lifestyle advice will be prepared, preferably together with relatives at the outpatient clinic. Participants will also have access to a website with written information and videos about HF and self-management. Finally, a pillbox will be delivered to facilitate drug adherence.

Intervention

Usual care treatment OTHER

Usual care treatment and follow-up care at the outpatient clinic and in primary care

Usual care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• The Hospital of Vestfold: collaborator
• University of Oslo: collaborator
• Oslo University Hospital: collaborator
• University of Stavanger: collaborator
• University Hospital, Akershus: collaborator

Study Sites (3)

Vestfold Hospital Trust

Tønsberg, Vestfold and Telemark County, 3103, Norway

Location

Vestre Viken Trust Drammen hospital

Drammen, Viken County, 3004, Norway

Location

Akershus University Hospital

Lørenskog, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: July 7, 2022
• Study Start: April 25, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

NO (3)