CARE-HK in HF: Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia

Sponsor
Vifor (International) Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04864795
Collaborator
(none)
5,000
Enrollment
28
Locations
48.4
Anticipated Duration (Months)
178.6
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients. For the purpose of this study, adherence to guidelines is defined as 1) adherence to potassium (sK+) monitoring recommendations, and 2) adherence to renin-angiotensin-aldosterone system inhibitor (RAASi) treatment recommendations, according to the most current local guidelines at the time of assessment.

The study aims to evaluate real-world RAASi treatment patterns in clinical practice compared with the guideline-directed medical therapy (GDMT) recommendations. Factors associated with patients achieving GDMT will be evaluated to identify potential barriers.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    The study will have a 24-month enrolment period, followed by a 24-month follow-up period, resulting in a total study duration of 48 months.

    At enrolment, relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis, as appropriate. After enrollment all patients will have between 24 months and 48 months of prospective follow-up.

    There are no visits or procedures associated with the study, patients will follow routine clinical care, which may include in-person and/or virtual visits. The study protocol does not recommend the use of any specific treatments and no study medication is provided as part of participation. The nature and heterogeneity of HF means patients will be treated with different treatments over the course of the study, and at the discretion of their treating physician.

    Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK in HF Registry)
    Actual Study Start Date :
    Apr 19, 2021
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2025

    Arms and Interventions

    ArmIntervention/Treatment
    Single Cohort

    Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients by RAASi optimisation overall [at 24-months following enrolment]

    2. Percentage of patients by RAASi optimisation following hyperkalaemic events [at 6-month intervals after a hyperkalaemic event]

    3. Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic events [at 24-months following enrolment]

    Secondary Outcome Measures

    1. Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation [at 24-months following enrolment]

    2. Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment [up to 48 months following enrolment]

    3. Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation [at enrolment and at approximately 6-months intervals]

      Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.

    2. Patient has at least 1 record of left ventricular ejection fraction (LVEF) documented in patient medical record in the 24 months prior to signature of informed consent.

    3. Patient treated with angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.

    4. Patient treated with or a candidate for treatment with mineralcorticoid receptor antagonist (MRA) per a relevant treatment guideline at enrolment.

    5. Patient at increased risk of hyperkalaemia due to one or more of the following:

    6. Current hyperkalaemia (sK+ >5.0 mEq/L) at enrolment

    7. Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior to signature of informed consent

    8. estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (CKD) stage ≥3b.

    9. Patient judged by the Investigator to have sufficient cognitive ability to participate

    Exclusion Criteria:
    1. Patient on renal replacement therapy or mechanical circulatory support.

    2. Disease other than HF with expected survival <1 year.

    3. Patient is participating in, or being screened for, an interventional trial.

    4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Investigator Site US148Boynton BeachFloridaUnited States33425
    2Investigator Site US130ClearwaterFloridaUnited States33756
    3Investigator Site US133ClearwaterFloridaUnited States33756
    4Investigator Site US153LargoFloridaUnited States33777
    5Investigator Site US104NaplesFloridaUnited States34102-8143
    6Investigator Site US118Port CharlotteFloridaUnited States33952
    7Investigator Site US154Safety HarborFloridaUnited States32695
    8Investigator Site US157Winter ParkFloridaUnited States32792
    9Investigator Site US122EatontonGeorgiaUnited States31024
    10Investigator Site US108Johns CreekGeorgiaUnited States30024
    11Investigator Site US110Hazel CrestIllinoisUnited States60429-2196
    12Investigator Site US134SpringfieldIllinoisUnited States62701
    13Investigator Site US124SalisburyMarylandUnited States21801
    14Investigator Site US103BridgetonMissouriUnited States63044
    15Investigator Site US114KalispellMontanaUnited States59901
    16Investigator Site US136SewellNew JerseyUnited States08080
    17Investigator Site US106AlbanyNew YorkUnited States12211
    18Investigator site US126Bay ShoreNew YorkUnited States11706
    19Investigator Site US163MarionOhioUnited States43302
    20Investigator Site US115Camp HillPennsylvaniaUnited States17011
    21Investigator site US132DallasTexasUnited States75390-9047
    22Investigator Site US120HoustonTexasUnited States77002
    23Investigator Site US105HoustonTexasUnited States77084
    24Investigator Site US119KingwoodTexasUnited States77339
    25Investigator Site US150McKinneyTexasUnited States75071
    26Investigator Site US128VictoriaTexasUnited States77901
    27Investigator Site IT101RomaItaly00163
    28Investigator Site CH103GenevaSwitzerland1211

    Sponsors and Collaborators

    • Vifor (International) Inc.

    Investigators

    • Study Director: Henrik Schou, Vifor (International) Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vifor (International) Inc.
    ClinicalTrials.gov Identifier:
    NCT04864795
    Other Study ID Numbers:
    • HQ-NIS-CHF-07.2020
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021