What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors can cause cough, elevated blood potassium levels, and low blood pressure. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Diuretics often result in electrolyte imbalances, dehydration, and kidney dysfunction. Aldosterone antagonists can cause hyperkalemia and gynecomastia. These side effects are important to monitor as they can impact the overall health status and quality of life of heart failure patients.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of heart failure, including ACE inhibitors (e.g., enalapril), beta-blockers (e.g., carvedilol), and angiotensin II receptor blockers (e.g., losartan). More recent approvals include neprilysin inhibitors combined with angiotensin receptor blockers (e.g., sacubitril/valsartan) and SGLT2 inhibitors (e.g., dapagliflozin) which have shown benefits in reducing heart failure hospitalizations and improving survival. These treatments aim to manage symptoms, improve quality of life, and reduce mortality, aligning with the goals of standardized health status assessments like the Kansas City Cardiomyopathy Questionnaire.

What other types of research exist?

Promising novel alternatives to the Kansas City Cardiomyopathy Questionnaire (KCCQ) for heart failure patients in 2024 include the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the EuroQoL 5D-3L (EQ-5D-3L). Additionally, advancements in telemedicine and digital health platforms may offer new methods for continuous and remote monitoring of patient health status.

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Patient-Reported Outcome Measurement for Heart Failure (PRO-HF Trial)

N/A

Waitlist Available

Led By Alexander T Sandhu, MD, MS

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one year post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using a 12-question survey during heart failure clinic visits helps improve patient care. Heart failure patients are split into two groups: one starts the survey immediately, and the other starts later. The study aims to see if regular health checks through the survey lead to better treatment and outcomes.

Who is the study for?

This trial is for patients who visit the Stanford Heart Failure clinic during the enrollment period. It's not open to those seen in the amyloid clinic.

What is being tested?

The study tests if using a health-related quality of life survey, called Kansas City Cardiomyopathy Questionnaire-12, affects patient outcomes and clinician decisions when given routinely at heart failure clinic visits.

What are the potential side effects?

Since this intervention involves completing a questionnaire rather than taking medication or undergoing medical procedures, there are no direct physical side effects associated with participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiomyopathies

Secondary study objectives

Average Daily Loop Diuretic Dose

Cardiovascular Diagnostic Test Frequency

Correlation Between Clinician and Patient Perception of Health Status

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)Experimental Treatment1 Intervention

Patients in the KCCQ-12 arm will undergo KCCQ-12 assessment of patient-reported heart failure health status in the electronic health record at each heart failure clinic visit beginning at the start of the trial. Assessment results will be available to clinicians in the electronic health record when making treatment decisions during each clinic visit.

Group II: Usual CareActive Control1 Intervention

Patients in the usual care arm will not complete KCCQ-12 assessments in the electronic health record with clinic visits. They will complete a KCCQ-12 assessment at baseline that will not be available to the treating clinician.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure (HF) work through various mechanisms to improve heart function and patient outcomes. ACE inhibitors and beta-blockers reduce the workload on the heart by lowering blood pressure and heart rate, respectively. Mineralocorticoid receptor antagonists help prevent fluid retention, reducing symptoms like swelling and shortness of breath. Sodium-glucose co-transporter 2 inhibitors not only manage blood sugar levels in diabetic patients but also have diuretic effects that benefit HF patients. Cardiac resynchronization therapy (CRT) improves the coordination of heart muscle contractions, enhancing overall cardiac efficiency. These treatments are crucial as they help alleviate symptoms, improve quality of life, and reduce the risk of hospitalization and mortality, which are key outcomes measured by the Kansas City Cardiomyopathy Questionnaire.