NCT07913152Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Sept 2026
- Start date
- 17 Jun 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07913152
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 17 Jun 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for continuous intravenous infusion of fluids or medications.
Other illness
- Clinically unstable medical condition or significant risk of developing hemodynamic or cardiovascular instability.
- Active significant non-cardiovascular comorbid condition, including acute ischemic stroke, active bleeding, severe exacerbation of pulmonary disease, or sepsis.
- History of non-adherence to medical treatment or failure to attend follow-up visits.
- Significant cognitive impairment interfering with the patient's ability to adhere to treatment or participate in education and self-care.
Lab values
- Hemoglobin \<8 g/dL.
- Estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m².
Other
- Pregnancy.
- Inability to provide informed consent.
- Uncontrolled pain.
- Residence in a facility that provides on-site medical care, such as a nursing facility.
- Inability to obtain peripheral intravenous access, including vascular access requiring ultrasound guidance.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.