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HF2 Registry: Understanding Heart Failure with PA Pressure Sensors

This registry, called HF2, is collecting information from people with heart failure who have a pulmonary artery (PA) pressure sensor implanted. These sensors help doctors monitor your heart's pressures. The study aims to learn more about how these sensors help manage heart failure and how different treatments affect patients. You might be able to join if you have NYHA Class III heart failure (meaning you have significant symptoms with everyday activities) and were previously hospitalized, or if you meet expanded FDA guidelines, such as having elevated BNP levels (a marker for heart failure) without hospitalization or NYHA Class II heart failure (meaning you have slight symptoms with everyday activities). Researchers will look at changes in your heart's pressures, echocardiograms (ultrasounds of your heart), and medications over time to understand the impact of these sensors.

Study design
This is an observational registry, meaning researchers will collect information without giving you a new treatment. It plans to include up to 2000 participants.
What's involved
You would consent to have your health information, including data from your PA pressure sensor, collected. You may also be approached for future research based on your data.
Compensation
Not stated in the trial record.
Follow-up
Your health information will be collected at the time of implant, and then at 3, 6, 12, 24, and 36 months after the implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06425848

HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Recruiting
Not specifiedAges 18+Observational
University of Kansas Medical Center
~2,000 participants
Updated 2024-05-22 on ClinicalTrials.gov
What's tested:Observational

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in hemodynamics
Measured over at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.
+7 more outcomes measured

Conditions

Heart Failure

Explore related trials

Heart FailureNPPB wt Allele

Where it's being run

12 sites across 10 states
Minnesota2
Texas2
California1
Indiana1
Kansas1
Missouri1
North Carolina1
Oregon1

Study leadership

  • Hirak Shah, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Kartik Munshi, MPH
[email protected]
913-945-6445
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Change in hemodynamicsat implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.

    Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant.

  • Changes in Echocardiogram (ECHO)at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available.

  • Medication changesat implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies.

  • Sodiumat implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.

  • Potassiumat implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.

  • Hemoglobinat implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

  • B-type natriuretic peptide (BNP)at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

  • aminoterminal pro B-type natriuretic peptide (NT-proBNP)at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant