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Retrospective arm for Heart Failure (HF2 Registry Trial)

N/A
Recruiting
Led By Hirak Shah, MD
Research Sponsored by University of Kansas Medical Center
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 at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Awards & highlights

Summary

The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
B-type natriuretic peptide (BNP)
Change in hemodynamics
Changes in Echocardiogram (ECHO)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Retrospective armExperimental Treatment1 Intervention
Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board).
Group II: Prospective armExperimental Treatment1 Intervention
Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Observational
2016
Completed Phase 2
~69650

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
472 Previous Clinical Trials
169,439 Total Patients Enrolled
5 Trials studying Heart Failure
389 Patients Enrolled for Heart Failure
Hirak Shah, MDPrincipal InvestigatorUniversity of Kansas Medical Center
~1333 spots leftby Dec 2030
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