Trial results for the Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF) study were posted on ClinicalTrials.gov on 2025-08-07. The trial did not demonstrate a statistically significant reduction in the primary composite outcome of heart failure hospitalizations (HFHs), intravenous diuretic visits, and all-cause mortality, with a hazard ratio of 0.88 (p=0.1624).
Background
Heart failure is a chronic, progressive condition affecting the heart's ability to pump blood efficiently, leading to symptoms such as shortness of breath, fatigue, and fluid retention. It encompasses various forms, including systolic and diastolic heart failure, and is often classified by the New York Heart Association (NYHA) functional classes, such as Class II and Class III. Effective management aims to reduce hospitalizations, improve quality of life, and extend survival. The GUIDE-HF IDE clinical trial sought to evaluate the effectiveness of the CardioMEMS™ HF System in a broader patient population, including those with heart failure and individuals at risk for future heart failure events or mortality.
Trial design
The GUIDE-HF study was a completed trial, designated as Phase NA, with an enrollment of 2358 participants. The trial investigated patients with Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure NYHA Class II, and Heart Failure NYHA Class III. The study's primary objective, as indicated by the key measurements and analyses, was to assess a composite outcome of heart failure hospitalizations (HFHs), intravenous diuretic visits, and all-cause mortality. The trial compared a treatment group, which utilized the CardioMEMS™ HF System, against a control group.
Key results
The trial reported several key measurements for the composite outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality:
- In the Randomized Arm - Treatment Group, the rate was 0.563 events per patient-year.
- In the Randomized Arm - Control Group, the rate was 0.640 events per patient-year.
Sensitivity analyses related to COVID-19 impact also provided measurements:
- Follow-up Based COVID-19 Sensitivity Analysis:
- Randomized Arm - Treatment Group [Pre-COVID-19]: 0.553 events per patient-year.
- Randomized Arm - Control Group [Pre-COVID-19]: 0.682 events per patient-year.
- Randomized Arm - Treatment Group [During COVID-19]: 0.597 events per patient-year.
- Randomized Arm - Control Group [During COVID-19]: 0.536 events per patient-year.
- Subject Based COVID-19 Sensitivity Analysis:
- Randomized Arm - Treatment Group (Pre-COVID-19): 0.710 events per patient-year.
- Randomized Arm - Control Group (Pre-COVID-19): 0.864 events per patient-year.
- Randomized Arm - Treatment Group (During COVID-19): 0.508 events per patient-year.
- Randomized Arm - Control Arm (During COVID-19): 0.539 events per patient-year.
- Event Based COVID-19 Sensitivity Analysis:
- Randomized Arm - Treatment Group [Excluding COVID-19 Related Events]: 0.563 events per patient-year.
- Randomized Arm - Control Group [Excluding COVID-19 Related Events]: 0.633 events per patient-year.
Key analyses for the composite outcome included:
- A Hazard Ratio (HR) of 0.88, with a 95.0% confidence interval of 0.74 to 1.05, and a p-value of 0.1624, calculated using the Anderson-Gill model (robust sandwich).
- Another Hazard Ratio (HR) of 0.51, with a 90.0% confidence interval of 0.44 to 0.6.
Further sensitivity analyses for the Hazard Ratio included:
- HR of 0.85 (95.0% CI: 0.7 to 1.03), with a p-value of 0.0958, using the Anderson-Gill model (robust sandwich).
- HR of 0.83 (95.0% CI: 0.68 to 1.01), with a p-value of 0.0644, using the Anderson-Gill model (robust sandwich).
- HR of 1.04 (95.0% CI: 0.61 to 1.77), with a p-value of 0.8867, using the Anderson-Gill model (robust sandwich).
- HR of 1.09 (95.0% CI: 0.7 to 1.7), with a p-value of 0.7119, using the Anderson-Gill model (robust sandwich).
What this means
The GUIDE-HF trial's primary analysis did not achieve statistical significance for its composite endpoint of heart failure hospitalizations, intravenous diuretic visits, and all-cause mortality, as indicated by the hazard ratio of 0.88 and a p-value of 0.1624. This suggests that, in the expanded patient population studied, the CardioMEMS™ HF System did not significantly reduce these combined events compared to the control group. While some sensitivity analyses showed trends toward reduction, they also did not reach conventional levels of statistical significance. The reported Hazard Ratio of 0.51, despite a narrow confidence interval, lacks a specified p-value or methodology in the provided data, limiting its interpretability in the context of the overall trial findings.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03387813, titled "Hemodynamic-GUIDEd Management of Heart Failure", were posted on 2025-08-07 on clinicaltrials.gov.