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HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry (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

No Placebo-Only Group

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.

Eligible Conditions

Heart Failure
Congestive Heart Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

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

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

Primary study objectives

B-type natriuretic peptide (BNP)

Change in hemodynamics

Changes in Echocardiogram (ECHO)

+5 more

Side effects data

From 2023 Phase 2 trial • 1380 Patients • NCT05004181

11%

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Part B - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part A - Cohort 5: 1 Dose of 30 μg BNT162b2 (Original Vaccine)

Part C - Cohort 8: 1 Dose of 30 μg BNT162b2 (Original Vaccine)

Part C - Cohort 7: 1 Dose of 30 μg BNT162b2 (B.1.1.529)

Part A - Cohort 2: 2 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part A - Cohort 1: 1 Dose of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part B - Cohort 4: 1 Dose 30 μg BNT162b2 (B.1.617.2)

Part A - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part B - Cohort 1: 1 Dose 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part A - Cohort 3: 1 Dose of 30 μg BNT162b2 (B.1.1.7)

Part A - Cohort 4: 1 Dose of 30 μg BNT162b2 (B.1.617.2)

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

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

~69680

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