Myocardial InfarctionHeart@HomeNCT07913152
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
A study testing Remote cardiovascular monitoring at home in people with Myocardial Infarction and Myocarditis Acute, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Myocarditis Acute, Pericarditis
- What is being tested?
- Remote cardiovascular monitoring at home
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Jun 2026to 31 Dec 2027
- 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.
- Residence in the Tel Aviv area, allowing accessibility of the treating team and a rapid response when required.
- Mental capacity to provide informed consent and the ability to understand and follow medical recommendations.
- Availability of a family member or caregiver who agrees to remain with the patient during the first 24 hours of Hospital-at-Home care and to be available for periodic assessments as needed. This requirement may be waived at the discretion of the patient and treating physician for highly independent patients.
- Suitable home environment with Wi-Fi connectivity to support remote monitoring.
- Adequate technological literacy of the patient or caregiver to use the required technology.
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- Clinically stable and at low risk of rapid deterioration, based on vital signs and initial assessments as determined by the treating physician.
- The primary indication for hospitalization is one of the following: acute myocardial infarction, pulmonary embolism, pericarditis/myocarditis, heart failure, following transcatheter valve replacement or repair, following pacemaker or implantable cardioverter-defibrillator implantation,.
- Disease-Specific Inclusion Criteria
- In addition to the general inclusion criteria, patients must meet the relevant disease-specific criteria:
- Acute Myocardial Infarction
- Acute myocardial infarction with or without ST-segment elevation (STEMI or NSTEMI), treated with primary percutaneous coronary intervention (PCI). The intervention must have been performed in a coronary artery other than the proximal left anterior descending (LAD) artery or left main coronary artery, with TIMI grade III flow at the end of the procedure, no additional critical coronary artery stenoses, an uncomplicated PCI without periprocedural complications, and preserved left ventricular systolic function (LVEF >45%).
- Pericarditis/Myocarditis
- Initial diagnosis of pericarditis or myocarditis, with no more than a mild pericardial effusion and preserved left ventricular systolic function (LVEF ≥50%).
- Pulmonary Embolism
- Low-intermediate-risk pulmonary embolism following echocardiographic and CT angiographic (CTA) assessment and treatment with oral or subcutaneous anticoagulation; or intermediate-high-risk pulmonary embolism following successful mechanical thrombectomy, with subsequent improvement in hemodynamic and echocardiographic parameters.
- Following Transcatheter Valve Replacement or Repair
- Patients following uncomplicated transcatheter aortic valve replacement (TAVR), or transcatheter edge-to-edge repair (TEER) of the mitral or tricuspid valve, with no clear indication for pacemaker implantation.
- Heart Failure
- Newly diagnosed (de novo) heart failure or worsening of pre-existing heart failure, regardless of left ventricular ejection fraction (LVEF), with symptomatic NYHA functional class II-IV heart failure requiring hospitalization.
- Following Pacemaker or Implantable Cardioverter-Defibrillator Implantation.
Who cannot join
- Pregnancy.
- Inability to provide informed consent.
- Clinically unstable medical condition or significant risk of developing hemodynamic or cardiovascular instability.
- Requirement for continuous intravenous infusion of fluids or medications.
- Uncontrolled pain.
- Active significant non-cardiovascular comorbid condition, including acute ischemic stroke, active bleeding, severe exacerbation of pulmonary disease, or sepsis.
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- Hemoglobin <8 g/dL.
- Estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m².
- History of non-adherence to medical treatment or failure to attend follow-up visits.
- Residence in a facility that provides on-site medical care, such as a nursing facility.
- Significant cognitive impairment interfering with the patient's ability to adhere to treatment or participate in education and self-care.
- Inability to obtain peripheral intravenous access, including vascular access requiring ultrasound guidance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shmuel Banai, MD contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Michal Laufer Perl, MD. MHA, 97236974388, michallp@tlvmc.gov.il
Shir Frydman, MD
About this study
Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients with acute cardiovascular conditions remains limited.
HeaRt@Home is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of H@H compared with standard in-hospital care in clinically stable cardiac patients admitted to Tel Aviv Sourasky Medical Center. The study will enroll 150 adults hospitalized for selected cardiovascular conditions, including acute myocardial infarction following uncomplicated percutaneous coronary intervention, pericarditis or myocarditis, pulmonary embolism, post transcatheter valvular intervention, acute or worsening heart failure, or following Pacemaker or Implantable Cardioverter-Defibrillator Implantation.
Read more
Eligible patients will be assessed within the first 12-24 hours following clinical intervention and randomized to either continued standard hospitalization or H@H care. Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
The study will assess safety outcomes including all-cause mortality, hospital-acquired infections, hemodynamic deterioration, acute kidney injury, venous thromboembolism, medication errors, 30-day readmission, and 30-day mortality. Patient experience will be evaluated using the 15-item Picker Patient Experience Questionnaire. Secondary outcomes will include length of stay, healthcare resource utilization, mobility and physical activity, sleep, arrhythmias, need for escalation to hospital care, and psychological outcomes.
The study aims to determine whether a structured, technology-supported H@H model can provide safe and effective hospital-level care for appropriately selected cardiovascular patients while potentially improving patient experience and optimizing healthcare resource utilization.
- Conditions
- Myocardial Infarction, Myocarditis Acute, Pericarditis, Pulmonary Embolism Acute, Heart Failure Acute, Transcatheter Valve Replacement
- Being tested
- Remote cardiovascular monitoring at home
- Keywords
- CARDIOLOGY, HOSPITAL AT HOME, REMOTE MONITORING, H@H, Heart@Home, Hospital-at-Home, cardiovascular
- Medical subject headings
- Myocardial Infarction, Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote cardiovascular monitoring at homeOther
Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
| Study group | Role | What they receive |
|---|---|---|
| Home monitoring | Experimental | Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy,and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required. Receives: Other: Remote cardiovascular monitoring at home |
| Standard hospital care | No intervention | Patients assigned to this arm will be monitored with the same continuous remote monitoring device and treated with the standard routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Safety Outcomes number of Events
The total number of events - Each of the following events will be contented is 1 unit: including all-cause mortality during hospitalization; Hospital-acquired infections; Hemodynamic deterioration requiring inotropic treatment and/or mechanical ventilation; Acute kidney injury according to KDIGO criteria; Deep vein thrombosis and/or pulmonary embolism; Medication administration errors; Hospital readmission within 30 days; and All-cause mortality within 30 days.
Measured: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
Patient Experience Questionnaire
The total score of the 15-item Picker Patient Experience Questionnaire.
Measured: Questionnaire filled at the day of discharge from admission, an average of 3-5 days, and refers to the hospitalization duration.
Secondary outcomes (1)
Composite Secondary Endpoints number of Events
Duration of hospitalization; Number of diagnostic tests performed during hospitalization, including laboratory tests, imaging examinations, Holter monitoring, and specialist consultations; Number and duration of intravenous treatments; Number of hours of oxygen treatment per day; Episodes of peripheral intravenous-line phlebitis; Episodes of venous thromboembolism; Episodes of acute kidney injury; Requirement for urinary catheterization; Medication administration errors; Falls; Mobility and number of active hours per day measured by continuous monitoring; Daily step count; Hours of sleep per day; Cardiac arrhythmias, including atrial fibrillation, atrial flutter, ventricular tachycardia, and second-degree or higher atrioventricular conduction abnormalities; Requirement for transfer from H@H to conventional hospital care; Number of daily nursing visits; Number of daily cardiologist assessments; Cardiac and all-cause hospital readmission within 30 days; All-cause mortality at 30 days;
Measured: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start17 Jun 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- SABAR HEALTH, SHL Telemedicine Ltd.
- Responsible party
- Principal investigator, Shmuel Kivity, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Shmuel Banai, MD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913152
- Sponsor's protocol ID
- 0368-25- TLV
- Acronym
- Heart@Home
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Achanta A, Wasfy JH, Moss CT, Cherukara A, Ho D, Boxer R, Schmieding M, Phadke NA, Thompson R, Levine DM, Weiner RB. Home Hospital Outcomes for Acute Decompensated Heart Failure and Factors Associated With Escalation of Care. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010031. doi: 10.1161/CIRCOUTCOMES.123.010031. Epub 2023 Dec 6.
PubMed 38054286Levine DM, Souza J, Schnipper JL, Tsai TC, Leff B, Landon BE. Acute Hospital Care at Home in the United States: The Early National Experience. Ann Intern Med. 2024 Jan;177(1):109-110. doi: 10.7326/M23-2264. Epub 2024 Jan 9. No abstract available.
PubMed 38190713Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.
PubMed 31842232
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
- ClinicalTrials.gov ID
- NCT07913152
- Acronym / sponsor ID
- Heart@Home / 0368-25- TLV
- Conditions
- Myocardial Infarction, Myocarditis Acute, Pericarditis, Pulmonary Embolism Acute, Heart Failure Acute, Transcatheter Valve Replacement
- Keywords
- CARDIOLOGY, HOSPITAL AT HOME, REMOTE MONITORING, H@H, Heart@Home, Hospital-at-Home, cardiovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- SABAR HEALTH, SHL Telemedicine Ltd.
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients with acute cardiovascular conditions remains limited.
HeaRt@Home is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of H@H compared with standard in-hospital care in clinically stable cardiac patients admitted to Tel Aviv Sourasky Medical Center. The study will enroll 150 adults hospitalized for selected cardiovascular conditions, including acute myocardial infarction following uncomplicated percutaneous coronary intervention, pericarditis or myocarditis, pulmonary embolism, post transcatheter valvular intervention, acute or worsening heart failure, or following Pacemaker or Implantable Cardioverter-Defibrillator Implantation.
Eligible patients will be assessed within the first 12-24 hours following clinical intervention and randomized to either continued standard hospitalization or H@H care. Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
The study will assess safety outcomes including all-cause mortality, hospital-acquired infections, hemodynamic deterioration, acute kidney injury, venous thromboembolism, medication errors, 30-day readmission, and 30-day mortality. Patient experience will be evaluated using the 15-item Picker Patient Experience Questionnaire. Secondary outcomes will include length of stay, healthcare resource utilization, mobility and physical activity, sleep, arrhythmias, need for escalation to hospital care, and psychological outcomes.
The study aims to determine whether a structured, technology-supported H@H model can provide safe and effective hospital-level care for appropriately selected cardiovascular patients while potentially improving patient experience and optimizing healthcare resource utilization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Home monitoring | Experimental | Other: Remote cardiovascular monitoring at homePatients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy,and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required. |
| Standard hospital care | No intervention | –Patients assigned to this arm will be monitored with the same continuous remote monitoring device and treated with the standard routine hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥18 years.
- Residence in the Tel Aviv area, allowing accessibility of the treating team and a rapid response when required.
- Mental capacity to provide informed consent and the ability to understand and follow medical recommendations.
- Availability of a family member or caregiver who agrees to remain with the patient during the first 24 hours of Hospital-at-Home care and to be available for periodic assessments as needed. This requirement may be waived at the discretion of the patient and treating physician for highly independent patients.
- Suitable home environment with Wi-Fi connectivity to support remote monitoring.
Key exclusion criteria (12 listed)
- Pregnancy.
- Inability to provide informed consent.
- Clinically unstable medical condition or significant risk of developing hemodynamic or cardiovascular instability.
- Requirement for continuous intravenous infusion of fluids or medications.
- Uncontrolled pain.
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 |
|---|---|---|
| Remote cardiovascular monitoring at homePatients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required. | Other | Home monitoring |
Primary outcome
Composite Primary Safety Outcomes number of Events
Time frame: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
The total number of events - Each of the following events will be contented is 1 unit: including all-cause mortality during hospitalization; Hospital-acquired infections; Hemodynamic deterioration requiring inotropic treatment and/or mechanical ventilation; Acute kidney injury according to KDIGO criteria; Deep vein thrombosis and/or pulmonary embolism; Medication administration errors; Hospital readmission within 30 days; and All-cause mortality within 30 days.
Patient Experience Questionnaire
Time frame: Questionnaire filled at the day of discharge from admission, an average of 3-5 days, and refers to the hospitalization duration.
The total score of the 15-item Picker Patient Experience Questionnaire.
1 secondary outcome
Composite Secondary Endpoints number of Events
Time frame: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
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 3 Nov 2026.
- Results publication: PubMed 38054286Achanta A, Wasfy JH, Moss CT, Cherukara A, Ho D, Boxer R, Schmieding M, Phadke NA, Thompson R, Levine DM, Weiner RB. Home Hospital Outcomes for Acute Decompensated Heart Failure and Factors Associated With Escalation of Care. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010031. doi: 10.1161/CIRCOUTCOMES.123.010031. Epub 2023 Dec 6.
- Results publication: PubMed 38190713Levine DM, Souza J, Schnipper JL, Tsai TC, Leff B, Landon BE. Acute Hospital Care at Home in the United States: The Early National Experience. Ann Intern Med. 2024 Jan;177(1):109-110. doi: 10.7326/M23-2264. Epub 2024 Jan 9. No abstract available.
- Results publication: PubMed 31842232Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.
- Individual participant dataSharing planned: No
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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.
Shmuel Banai, MD contact
Shmuel Banai, MD study director
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote cardiovascular monitoring at home in people with Myocardial Infarction and Myocarditis Acute, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 21 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Contact Michal Laufer Perl, MD, MHA (97236974388, michallp@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Primary Safety Outcomes number of Events (time frame: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge). 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 NCT07913152, which also lists 3 linked publications.
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 3 Nov 2026.