Trial · NCT07896863
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Outcome of Phase 1: New-incident heart-failure diagnosis | 6 months after baseline | (1) HFrEF - symptomatic cardiac dysfunction with LVEF \< 50%; (2) HFpEF - symptoms of HF with LVEF ≥ 50% and echocardiographic evidence of structural or functional cardiac abnormalities; or (3) hospitalisation with heart failure as a primary cause. |
| Primary | Primary Outcome of Phase 2: Composite Cardiovascular Outcome | 18 months after baseline | The composite outcome includes cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency department visits due to atrial fibrillation. |
| Primary | Primary Outcome of Extension Study: Composite cardiovascular outcome | 36 months after baseline | Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation. |
| Secondary | The proportion of patients who met all the three criteria for the ABC pathway adherence | 6 months | Proportion of participants meeting all three ABC criteria. 'A' (avoid stroke): appropriate oral anticoagulation according to guideline indications, defined as use of an appropriately dosed direct oral anticoagulant or warfarin with time in therapeutic range \>65%.Patients who were not properly treated with OACs are considered as 'A non-compliant'. 'B' (Better functional status): Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. 'C' (comorbidity and cardiovascular risk-factor management): 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'. |
| Secondary | GDMT medication utilization rate | 6 months | The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%. |
| Secondary | Incidence and Time to Cardiovascular Death | 18 months | Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime |
| Secondary | Incidence and Time to Ischemic or Hemorrhagic Stroke | 18 months | All strokes: ischemic or hemorrhagic Stroke |
| Secondary | Incidence and Time to Hospitalization for Worsening Heart Failure or Acute Coronary Syndrome | 18 months | Hospitalization due to worsening heart failure or acute coronary syndrome during follow-up. |
| Secondary | Incidence and Time to Emergency visit due to Atrial Fibrillation | 18 months | Occurrence of an emergency department visit due to atrial fibrillation during follow-up |
| Secondary | All-Cause Mortality | 18 months | Death from any cause during the follow-up period. |
| Secondary | The proportion of patients who met all the three criteria for the ABC pathway adherence | 18 months | Proportion of participants meeting all three ABC criteria. 'A' (avoid stroke): appropriate oral anticoagulation according to guideline indications, defined as use of an appropriately dosed direct oral anticoagulant or warfarin with time in therapeutic range \>65%.Patients who were not properly treated with OACs are considered as 'A non-compliant'. 'B' (Better functional status): Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. 'C' (comorbidity and cardiovascular risk-factor management): 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'. |
| Secondary | GDMT medication utilization rate | 18 months | The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07896863/registered