N/A
N=1,249
Patient-Reported Outcome Measurement in Heart Failure Clinic
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04164004 ↗Enrolled (actual)
1,249
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Kansas City Cardiomyopathy Questionnaire-12 Score — 79.4; 79.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kansas City Cardiomyopathy Questionnaire-12 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kansas City Cardiomyopathy Questionnaire-12 Score |
79.4; 79.7 | — |
| PRIMARY Kansas City Cardiomyopathy Questionnaire-12 Response Rate |
1331 | — |
| SECONDARY Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction |
— | — |
| SECONDARY Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Median Dose of Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Preserved/Mid-range Ejection Fraction. |
— | — |
| SECONDARY Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Left Ventricular Ejection Fraction > 40%. |
— | — |
| SECONDARY Percentage of Patients on Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy |
— | — |
| SECONDARY Median Dose of Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy |
— | — |
| SECONDARY Percentage of Patients With a Implantable Cardiac Defibrillator Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Percentage of Patients With a Cardiac Resynchronization Therapy Device Among Patients With Reduced Ejection |
— | — |
| SECONDARY Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients With Reduced Ejection Fraction |
— | — |
| SECONDARY Number of Medication Adjustments Per Heart Failure Clinic Visit |
— | — |
| SECONDARY Average Daily Loop Diuretic Dose |
— | — |
| SECONDARY Count of Hospitalizations Per Patient |
— | — |
| SECONDARY Count of Emergency Department Visits Per Patient |
— | — |
| SECONDARY Count of Heart Failure Clinic Visits Per Patient |
— | — |
| SECONDARY Count of Telephone Encounters Per Patient |
— | — |
| SECONDARY Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation |
— | — |
| SECONDARY Quality of Patient Clinic Experience |
— | — |
| SECONDARY Correlation Between Clinician and Patient Perception of Health Status |
— | — |
| SECONDARY Cardiovascular Diagnostic Test Frequency |
— | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Heart Failure or Cardiomyopathy |
— | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Sub-optimal Health Status at Baseline |
— | — |
| SECONDARY Number of Total Heart Failure Medication Adjustments |
— | — |
Summary
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.
Eligibility Criteria
Inclusion Criteria
- Stanford Heart Failure clinic visit during enrollment period
Exclusion Criteria
- Seen in amyloid clinic
Data sourced from ClinicalTrials.gov (NCT04164004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.