Heart Failure AcuteNCT05447598
Remote Monitoring After Heart Failure
A study testing Nurse-led remote monitoring program in people with Heart Failure Acute and Remote Monitoring, run by Vestre Viken Hospital Trust at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute, Remote Monitoring, Nurse's Role
- What is being tested?
- Nurse-led remote monitoring program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesNorway
- Study dates
- 25 Apr 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Vestre Viken Trust Drammen hospital
Drammen, Viken County, 3004
Akershus University Hospital
Lørenskog
Vestfold Hospital Trust
Tønsberg, Vestfold and Telemark County, 3103
About this study
Official title: Individually Tailored Remote Monitoring at Home After Hospitalisation for HEART Failure in Multi-morbid Patients (IT-HEART): a Randomised Clinical Trial
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
- Being tested
- Nurse-led remote monitoring program, Usual care treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led remote monitoring programOther
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.
Usual care treatmentOther
Usual care treatment and follow-up care at the outpatient clinic and in primary care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Remote monitoring program Receives: Other: Nurse-led remote monitoring program |
| Usual care | Active comparator | Current clinical pratice at the participating hospitals Receives: Other: Usual care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From time of randomization until 12 months follow-up
Secondary outcomes (7)
Rate of total death
Rate of total death at 12 months follow-up assessed from hospital medical records between the treatment arms
Measured: From time of randomization until 12 months follow-up
Rate of unplanned re-hospitalizations
Rate of re-hospitalizations at 12 months follow-up assessed from hospital medical records between the treatment arms
Measured: From time of randomization until 12 months follow-up
Total number of days lost due to unplanned heart failure admissions treatment arms
Percentage of days lost due to unplanned heart failure admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Measured: From time of randomization until 12 months follow-up
Total number of days lost due to unplanned hospital admissions treatment arms
Percentage of days lost due to unplanned hospital admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Measured: From time of randomization until 12 months follow-up
Changes in selfcare behaviour
Changes in selfcare behaviour measured by the revised 9-item European Heart Failure Selfcare behaviour Scale assessed by patient self-report on a five-point scale from "totally agree" to "totally disagree".
Measured: From baseline until three months follow-up
Changes in health-related quality of life
Changes in health-related quality of life measured by Kansas Cardiomyopathy Questionnaire 12-score (higher scores indicating better outcome).
Measured: From baseline until three months follow-up
Changes in symptom score and patient satisfaction
Changes in symptom score and patient satisfaction measured by the Edmonton Symptom Assessment System Revised scores (higher scores indicating better outcome).
Measured: From baseline until three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start25 Apr 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Vestfold, University of Oslo, Oslo University Hospital, University of Stavanger, University Hospital, Akershus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447598
- Sponsor's protocol ID
- 464460
- Status last verified
- Sep 2025
- First submitted
- 27 May 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Braanaas KS, Dammen T, Fagerland MW, Husebye E, Leinaas A, Schirmer H, Sverre E, Aune E, Myhre PL, Munkhaugen J. Individually tailored monitoring at home after hospitalization for HEART failure (IT-HEART): design and baseline characteristics of a randomized clinical trial. Heart Fail Rev. 2026 Apr 22;31(1):61. doi: 10.1007/s10741-026-10635-1.
PubMed 42018019
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Remote Monitoring at Home After Hospitalisation for HEART Failure in Multi-morbid Patients (IT-HEART): a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05447598
- Acronym / sponsor ID
- 464460
- Conditions
- Heart Failure Acute, Remote Monitoring, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- The Hospital of Vestfold, University of Oslo, Oslo University Hospital, University of Stavanger, University Hospital, Akershus
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Nurse-led remote monitoring programRemote monitoring program |
| Usual care | Active comparator | Other: Usual care treatmentCurrent clinical pratice at the participating hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led remote monitoring programSymptoms 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. | Other | Intervention |
| Usual care treatmentUsual care treatment and follow-up care at the outpatient clinic and in primary care | Other | Usual care |
Primary outcome
Rate of re-hospitalizations for heart failure
Time frame: From time of randomization until 12 months follow-up
Rate of re-hospitalizations for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms
Time to first re-hospitalization for heart failure
Time frame: From time of randomization until 12 months follow-up
Time to first re-hospitalization for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms
7 secondary outcomes
Rate of total death
Time frame: From time of randomization until 12 months follow-up
Rate of unplanned re-hospitalizations
Time frame: From time of randomization until 12 months follow-up
Total number of days lost due to unplanned heart failure admissions treatment arms
Time frame: From time of randomization until 12 months follow-up
Total number of days lost due to unplanned hospital admissions treatment arms
Time frame: From time of randomization until 12 months follow-up
Changes in selfcare behaviour
Time frame: From baseline until three months follow-up
Changes in health-related quality of life
Time frame: From baseline until three months follow-up
Changes in symptom score and patient satisfaction
Time frame: From baseline until three months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42018019Braanaas KS, Dammen T, Fagerland MW, Husebye E, Leinaas A, Schirmer H, Sverre E, Aune E, Myhre PL, Munkhaugen J. Individually tailored monitoring at home after hospitalization for HEART failure (IT-HEART): design and baseline characteristics of a randomized clinical trial. Heart Fail Rev. 2026 Apr 22;31(1):61. doi: 10.1007/s10741-026-10635-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led remote monitoring program in people with Heart Failure Acute and Remote Monitoring, run by Vestre Viken Hospital Trust at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-hospitalizations for heart failure (time frame: From time of randomization until 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.