Clinical Trial Overview: The EMAIL-HF Study
A registry-based randomized trial known as EMAIL-HF evaluated whether a direct-to-patient digital health strategy could improve the adoption of guideline-directed medical therapy for heart failure (HF). Presented at the European Society of Cardiology (ESC) Congress in Munich, the study investigated a proactive outreach model utilizing existing government health data to address treatment gaps in patients not currently prescribed sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Dr. Mariam Elmegaard, PhD, from Herlev and Gentofte University Hospital in Copenhagen, Denmark, explained the rationale behind the intervention during a press conference:
“many eligible patients still do not receive the treatment due to, for example, fragmented healthcare, and also because many patients with longstanding heart failure are no longer under specialist follow-up, and therefore may lag behind current standards of care.”
Study Design and Intervention
The trial identified all patients with a diagnosis of HF within the Capital Region of Denmark and the municipality of Roskilde who were not actively receiving an SGLT2 inhibitor. A total of 5,996 patients met the eligibility criteria between May 2023 and June 2024.
Participants were randomized into either a digital strategy intervention group or a standard care control group. Patients assigned to the digital strategy received an electronic communication via the Danish government’s Digital Post system. This communication provided targeted information regarding the benefits of SGLT2 inhibitors and extended an invitation for a telephone consultation with an HF specialist.
Describing the methodology, Dr. Elmegaard noted:
“We screened all the patients with heart failure who were not in therapy with SGLT2 inhibitors in the Capital Region of Denmark, and then invited them to be evaluated by a heart failure specialist for potential SGLT2 inhibitor treatment. The control group were not aware that they had been randomized, so they were just followed in the Danish registries.”
Key Results and Clinical Metrics
Among participants allocated to the digital intervention arm, 60% responded to the electronic communication, and 31% of those respondents subsequently initiated SGLT2 inhibitor therapy following specialist consultation.
| Metric / Endpoint | Digital Strategy Group | Control Group (Usual Care) | Statistical Measure / Effect |
| Cohort Size | 2,998 (approx. split) | 2,998 (approx. split) | Total Study Cohort: $N = 5,996$ |
| Email Response Rate | 60% | N/A | Direct digital engagement metric |
| Therapy Initiation Rate | 31% of respondents | N/A | Post-consultation uptake |
| 6-Month SGLT2i Uptake | Higher baseline adoption | Lower baseline adoption | $\text{RR} = 2.28$ (95% CI, 1.98โ2.63; $P < .0001$) |
| Clinical Outcomes (Death/HF Hospitalization) | Lower numerical events | Higher numerical events | $\text{HR} = 0.92$ (95% CI, 0.81โ1.06; $P = .263$) |
| Severe Adverse Events | Comparable safety profile | Comparable safety profile | No significant difference reported |
At the 6-month assessment mark, the uptake of SGLT2 inhibitors was 128% higher in the digital strategy cohort compared to usual care ($\text{RR} = 2.28$; 95% CI, 1.98โ2.63; $P < .0001$), with the therapeutic effect remaining sustained out to 24 months. Although the trial was not formally powered to evaluate hard clinical endpoints, secondary observations indicated that composite rates of all-cause death and heart failure hospitalization were numerically lower in the intervention group ($\text{HR} = 0.92$; 95% CI, 0.81โ1.06; $P = .263$), with no observed differences in severe adverse events between cohorts.
Summarizing the clinical implications, Dr. Elmegaard stated:
“This relatively simple digital strategy more than doubled the uptake of guideline-recommended SGLT2 inhibitor therapy in patients with heart failure, compared with usual care, and this could provide a new pathway for timely implementation of evidence-based therapies in routine clinical care, also beyond heart failure.”
She further emphasized:
“For the patients using existing health data, healthcare systems can now proactively identify and reach patients who may have limited contact to the healthcare system and are missing recommended treatment. Our take-home message for today is that there is enormous potential in using health data to rapidly identify and close treatment gaps in heart failure, thereby reducing delays and saving precious time in a life-threatening condition such as heart failure.”
Expert Perspective
Providing an independent clinical perspective, Dr. Anekwe E. Onwuanyi (Morehouse School of Medicine and Grady Memorial Hospital) observed that the approach operates similarly to a direct-to-consumer educational model that successfully mitigates clinical inertia and administrative barriers. However, he noted that structural differences between the Danish healthcare system and models in the United Statesโparticularly regarding care fragmentation and medication affordabilityโmay require adaptation, suggesting that integrated delivery networks like the Veterans Affairs system or Kaiser Permanente could serve as viable environments for similar implementations if medication cost hurdles are addressed.
Zero-CLS Interactive Widget Code for WordPress (Soledad Theme)
To prevent Cumulative Layout Shift (CLS) on a WordPress site using the Soledad theme, the widget container must maintain strict dimensions using modern CSS containment and explicit aspect ratios or minimum heights.
HTML
<div class="email-hf-widget-wrapper" style="contain: layout size style; min-height: 420px; width: 100%;">
<div id="emailHfCalculator" class="soledad-custom-widget" style="background: #f9f9f9; border: 1px solid #e5e5e5; padding: 20px; border-radius: 8px; box-sizing: border-box;">
<h3 style="margin-top: 0; font-size: 18px; color: #333;">EMAIL-HF Uptake Estimator</h3>
<p style="font-size: 14px; color: #666;">Estimate potential SGLT2 inhibitor uptake improvements using registry-based digital outreach.</p>
<div style="margin-bottom: 15px;">
<label for="patientPool" style="display: block; font-weight: 600; margin-bottom: 5px;">Eligible HF Patient Population Size:</label>
<input type="number" id="patientPool" value="1000" style="width: 100%; padding: 8px; box-sizing: border-box; border: 1px solid #ccc; border-radius: 4px;" />
</div>
<button onclick="calculateUptake()" style="background: #0056b3; color: #fff; border: none; padding: 10px 15px; border-radius: 4px; cursor: pointer; font-weight: 600;">Calculate Projected Uptake</button>
<div id="widgetResult" style="margin-top: 15px; font-weight: bold; color: #0056b3; min-height: 24px;"></div>
</div>
</div>
<script>
function calculateUptake() {
const pool = document.getElementById('patientPool').value;
const responders = pool * 0.60;
const initiators = Math.round(responders * 0.31);
document.getElementById('widgetResult').innerText = `Projected New SGLT2i Initiations: ~${initiators} patients (${Math.round((initiators/pool)*100)}% of total cohort)`;
}
</script>
Zero-CLS Clinical Trial Summary HTML Code
HTML
<div class="clinical-trial-summary-container" style="contain: layout size style; min-height: 350px; width: 100%; font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; border-left: 4px solid #0056b3; background: #fff; padding: 20px; box-shadow: 0 2px 4px rgba(0,0,0,0.05); box-sizing: border-box;">
<h4 style="margin: 0 0 10px 0; font-size: 20px; color: #1a1a1a;">EMAIL-HF Trial Summary</h4>
<ul style="margin: 0; padding-left: 20px; font-size: 14px; color: #444; line-height: 1.6;">
<li><strong>Study Design:</strong> Registry-based randomized trial evaluating a digital outreach strategy vs. usual care.</li>
<li><strong>Intervention:</strong> Automated digital mail notification with clinical information and specialist consultation scheduling.</li>
<li><strong>Primary Endpoint:</strong> 128% relative increase in SGLT2 inhibitor uptake at 6 months ($\text{RR} = 2.28$; $P < .0001$).</li>
<li><strong>Safety Profile:</strong> No significant differences in severe adverse events between intervention and control arms.</li>
<li><strong>Presentation:</strong> European Society of Cardiology (ESC) Congress, Munich.</li>
</ul>
</div>