Heart FailureHF2 RegistryNCT06425848
HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
An observational study of Heart Failure, run by University of Kansas Medical Center at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Observational
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Oct 2022to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have been or will be implanted with PA pressure sensor.
Who may be able to join
- All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
- Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
Who cannot join
- Patients less than 18 years of age.
- Pregnant women at the scheduled time of PA pressure sensor implant.
- Patients unable or unwilling to have continuity of care in the heart failure clinic.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Austin Heart
Austin, Texas, 78756
Kunjan Bhatt, MS
Kunjan Bhatt, MD
- Recruiting
Indiana University
Bloomington, Indiana, 47401
Maya Guglin, MD
Maya Guglin, MD
- Recruiting
Prisma Health
Columbia, South Carolina, 29203
Suzanne Amaker
Patrick McCann, MD
- Recruiting
Houston Methodist DeBakey Heart and Vascular Center
Houston, Texas, 77030
Saba Khan
Ashrith Guha, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kartik Munshi, MPH, kmunshi@kumc.edu
Hirak Shah, MD
- Recruiting
Saint Luke's Health System
Kansas City, Missouri, 64131
Timothy Fendler, MD
Timothy Fendler, MD
- Recruiting
Scripps Health
La Jolla, California, 92037
Timothy Jordan, MD
Thomas Heywood, MD
- Not yet recruiting
Fairview Health
Maplewood, Minnesota, 55109
Terrie-Ann Benjamin, MD
Terrie-Ann Benjamin, MD
- Recruiting
Minneapolis Heart Institute Foundation/ Allina Health
Minneapolis, Minnesota, 55407
Sarah Schwager, RN
Mosi Bennett, MD
- Recruiting
Providence Heart Institute
Portland, Oregon, 97225
Christy Lenhart, RN
Jacob Abraham, MD
- Recruiting
University of North Carolina/ Rex Hospital, Inc.
Raleigh, North Carolina, 27607
Elizabeth Volz, MD
Elizabeth Volz, MS
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57104
Orvaar Jonsson, MD
Orvaar Jonsson, MD
About this study
Official title: Hemodynamic Frontiers in Heart Failure Registry
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.
Read the detailed description
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
- Conditions
- Heart Failure
- Being tested
- Observational
- Keywords
- Pulmonary Artery (PA) pressure monitor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDevice
We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective arm | 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). Receives: Device: Observational | |
| Prospective arm | 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. Receives: Device: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemodynamics
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.
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Changes in Echocardiogram (ECHO)
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.
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Medication changes
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.
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Sodium
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.
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Potassium
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.
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Hemoglobin
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
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
B-type natriuretic peptide (BNP)
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
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
aminoterminal pro B-type natriuretic peptide (NT-proBNP)
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
Measured: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start21 Oct 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hirak Shah, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425848
- Sponsor's protocol ID
- STUDY00147383
- Acronym
- HF2 Registry
- Status last verified
- May 2024
- First submitted
- 29 Feb 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Frontiers in Heart Failure Registry
- ClinicalTrials.gov ID
- NCT06425848
- Acronym / sponsor ID
- HF2 Registry / STUDY00147383
- Conditions
- Heart Failure
- Keywords
- Pulmonary Artery (PA) pressure monitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective arm | – | Device: ObservationalPatients 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). |
| Prospective arm | – | Device: ObservationalPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been or will be implanted with PA pressure sensor.
Key inclusion criteria (2 listed)
- All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
- Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
Key exclusion criteria (3 listed)
- Patients less than 18 years of age.
- Pregnant women at the scheduled time of PA pressure sensor implant.
- Patients unable or unwilling to have continuity of care in the heart failure clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalWe are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors. | Device | Prospective arm, Retrospective arm |
Primary outcome
Change in hemodynamics
Time frame: at 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)
Time frame: 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 changes
Time frame: at 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.
Sodium
Time frame: at 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.
Potassium
Time frame: at 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.
Hemoglobin
Time frame: at 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)
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hirak Shah, MD principal investigator
University of Kansas Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Kansas Medical Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kartik Munshi, MPH (913-945-6445, kmunshi@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemodynamics (time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.