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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

PRO-HF Trial Summary

This trial is testing whether collecting a standardized questionnaire on heart failure health status during clinic visits affects patient outcomes and clinician decision-making.

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.Check my eligibility

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.See study design

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.

PRO-HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiomyopathies

Secondary outcome measures

Average Daily Loop Diuretic Dose

Cardiovascular Diagnostic Test Frequency

Correlation Between Clinician and Patient Perception of Health Status

+29 more

PRO-HF 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,390 Previous Clinical Trials

17,339,479 Total Patients Enrolled

18 Trials studying Heart Failure

55,110 Patients Enrolled for Heart Failure

Alexander T Sandhu, MD, MSPrincipal InvestigatorInstructor of Medicine

1 Previous Clinical Trials

173 Total Patients Enrolled

Paul A Heidenreich, MDPrincipal InvestigatorProfessor of Medicine

Media Library

Kansas City Cardiomyopathy Questionnaire-12 Clinical Trial Eligibility Overview. Trial Name: NCT04164004 — N/A

Heart Failure Research Study Groups: Usual Care, Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)

Heart Failure Clinical Trial 2023: Kansas City Cardiomyopathy Questionnaire-12 Highlights & Side Effects. Trial Name: NCT04164004 — N/A

Kansas City Cardiomyopathy Questionnaire-12 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164004 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims does this experiment seek to realize?

"This trial's primary outcome, which will be assessed at least a year after enrolment or via telephone interview 15 months later, is to measure patient response rates as indicated by the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcomes include finding the median dose of beta blocker therapy among those with reduced ejection fraction; locating the median dosage for mineralocorticoid receptor antagonist amongst patients with low left ventricular ejection fractions; and identifying average hydralazine/nitrate dosages prescribed to African American participants suffering from lower than normal levels of heart output."

Answered by AI

Is there still availability for potential participants in this research trial?

"The clinicaltrials.gov site shows that this particular trial, with its initial postdate on August 30th 2021 and most recent edit on September 27th 2022, is not recruiting participants at the moment. Despite this, there are over 700 other trials which require patient participation currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient-Reported Outcome Measurement in Heart Failure Clinic

Alexander Sandhu 2021. "Patient-Reported Outcome Measurement in Heart Failure Clinic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04164004.