This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
TIM-HF2 was a randomized phase 3 parallel-group trial evaluating Remote Patient Management versus usual care in patients with chronic heart failure.
| Feature | TIM-HF2 |
|---|---|
| Title | Telemedical Interventional Management in Heart Failure II |
| NCT ID | NCT01878630 |
| Status | COMPLETED |
| Start date | 2013-08-08 |
| Primary completion date | 2017-05-12 |
| Lead sponsor | Charite University, Berlin, Germany |
| Condition | Chronic Heart Failure |
| Design | Randomized, parallel, non-masked |
2. Clinical Question
Population
Patients with chronic heart failure.
Intervention
Remote Patient Management (device).
Comparator
Usual Care.
Primary question
Whether Remote Patient Management affects the percentage of days lost due to unplanned cardiovascular hospitalisation or death for any reason during individual patient follow-up time.
3. Trial Design
Randomize
1571 patients
Intervention
Remote management
Comparator
Usual care
Follow-up
Individual patient time
Analysis
Primary endpoint
Remote Patient Management
Device-based Remote Patient Management intervention.
Usual Care
Usual Care comparator arm.
4. Endpoints
| Endpoint | Definition | Time frame |
|---|---|---|
| Primary endpoint | Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time. | 12 months / individual-patient follow-up time |
5. Statistical Methodology
The registry states that the primary outcome analysis will be performed on the Full Analysis Set (FAS) using adjudicated data. Sensitivity analyses will be performed on the Per Protocol (PP) data set and on the FAS censoring all data at day 365.
Full Analysis Set: primary outcome analysis population specified by the registry.
Per Protocol Set: sensitivity analysis population specified by the registry.
6. Planned Analysis
No results have been posted on ClinicalTrials.gov. The registry describes the endpoint that will be measured and the planned analysis populations, but does not report estimates, confidence intervals, p-values, or treatment-group outcome values.
For an endpoint combining cardiovascular hospitalization burden and mortality over follow-up time, an appropriate analysis generally requires methods that account for patient follow-up duration and competing clinical events. The prespecified FAS and PP sensitivity analyses are designed to evaluate robustness of the primary comparison under different analysis populations.
7. Statistical Methods Explained
Why analyze the percentage of days lost?
This endpoint combines hospitalization burden and mortality into a measure based on time affected by adverse cardiovascular outcomes. It focuses on the amount of follow-up time impacted rather than only counting events.
Why use a Full Analysis Set?
The Full Analysis Set maintains the randomized comparison framework and is commonly used for primary analyses because it preserves the benefits of randomization.
Why perform a Per Protocol sensitivity analysis?
A Per Protocol analysis examines whether the findings are consistent among participants who followed the assigned study procedures more closely. Because exclusions can affect comparability, it is generally interpreted as a sensitivity analysis rather than a replacement for randomized analysis.
Why use adjudicated data?
Adjudication applies a standardized review process to clinical events, helping define outcomes consistently across study groups.
Why censor data at day 365?
Censoring follow-up at a specified time point creates a sensitivity analysis focused on outcomes occurring within that defined observation period.
8. Limitations
- The registry does not report posted statistical results for the primary endpoint.
- The registry does not report treatment-effect estimates, confidence intervals, or p-values.
- The primary endpoint combines cardiovascular hospitalization and mortality-related information, which requires careful interpretation of the statistical framework used.
- The study was open-label because masking was listed as none; knowledge of treatment assignment can influence some trial processes.
9. Why This Trial Matters Statistically
| Concept | How it appears in TIM-HF2 |
|---|---|
| Randomization | Randomized comparison between two intervention strategies. |
| Parallel design | Two-arm parallel-group structure. |
| Composite outcome | Primary endpoint combines cardiovascular hospitalization burden and death. |
| Analysis populations | Full Analysis Set with Per Protocol sensitivity analysis. |
| Adjudicated outcomes | Primary analysis uses adjudicated data. |