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
85
48.4
58.8
1.2

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 Disease Intervention/Treatment Phase

    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

    Arm Intervention/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

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 UC San Diego Sulpizio Cardiovascular Center La Jolla California United States 92037
    3 Amicis Research Center Northridge California United States 91324
    4 Bridgeport Hospital Bridgeport Connecticut United States 06610
    5 Bethesda Hospital East Boynton Beach Florida United States 33425
    6 Clearwater Cardiovascular Consultants Clearwater Florida United States 33756
    7 Innovative Research of West Florida, Inc. Clearwater Florida United States 33756
    8 Inpatient Research Clinic, LLC Hialeah Florida United States 33013
    9 Clearwater Cardiovascular Consultants Largo Florida United States 33777
    10 D&H National Research Centers Miami Florida United States 33173
    11 Southwest Florida Research, LLC Naples Florida United States 34102-8143
    12 Peace River Cardiovascular Center Port Charlotte Florida United States 33952
    13 Clearwater Cardiovascular and Interventional Consultants Safety Harbor Florida United States 32695
    14 Florida Cardiology P.A Winter Park Florida United States 32792
    15 IACT Health Columbus Georgia United States 31904
    16 Cardiology Care Clinics Eatonton Georgia United States 31024
    17 NSC Research Johns Creek Georgia United States 30024
    18 Chicago Medical Research, LLC Hazel Crest Illinois United States 60429-2196
    19 Prairie Cardiovascular Consultants, Ltd. Springfield Illinois United States 62701
    20 Cardiovascular Medicine, P.C. Davenport Iowa United States 52803
    21 Central Cardiology Associates Elizabethtown Kentucky United States 42701
    22 Maine Health Biddeford Maine United States 04005
    23 Johns Hopkins University Baltimore Maryland United States 21218
    24 TidalHealth Peninsula Regional Inc. Salisbury Maryland United States 21801
    25 Ascension St. Mary's Hospital Saginaw Michigan United States 48601
    26 Minneapolis Heart Institute Foundation Minneapolis Minnesota United States 55407
    27 St. Louis Heart and Vascular Bridgeton Missouri United States 63044
    28 St. Louis University Saint Louis Missouri United States 63104
    29 Logan Health Research Kalispell Montana United States 59901
    30 Raritan Bay Primary and Cardiology Associates Matawan New Jersey United States 07747
    31 The Heart House Sewell New Jersey United States 08080
    32 Albany Stratton VA Medical Center Albany New York United States 12208
    33 Capital Cardiology Associates Albany New York United States 12211
    34 South Shore University Hospital Bay Shore New York United States 11706
    35 Focus Clinical Research Solutions Charlotte North Carolina United States 28204
    36 Nephrology Associates of Greater Cincinnati Cincinnati Ohio United States 45236
    37 Rama Research LLC Marion Ohio United States 43302
    38 The Heart and Medical Center Durant Oklahoma United States 74701
    39 Capital Area Research, LLC Camp Hill Pennsylvania United States 17011
    40 UPMC Presbyterian Hospital Pittsburgh Pennsylvania United States 15213
    41 UT Southwestern Medical Center Dallas Texas United States 75390-9047
    42 East Texas Cardiology PA Houston Texas United States 77002
    43 Biopharma Informatic, LLC Houston Texas United States 77084
    44 Texas Cardiology Associates of Houston Kingwood Texas United States 77339
    45 Complete Heart Care McKinney Texas United States 75071
    46 Baylor Scott & White Round Rock Round Rock Texas United States 78665
    47 Baylor Scott & White Health - Temple Temple Texas United States 76508
    48 Victoria Heart & Vascular Center Victoria Texas United States 77901
    49 Richmond Cardiology Associates Mechanicsville Virginia United States 23116
    50 William S. Middleton Memorial VA Hospital Madison Wisconsin United States 53705
    51 KH St. Josef Braunau Braunau Am Inn Austria
    52 Allgemeines Krankenhaus der Stadt Wien Wien Austria
    53 Imed-19 privat Wien Austria
    54 Klinik Floridsdorf Wien Austria
    55 Cliniques Universitaires de Bruxelles Hopital Erasme Brussels Belgium
    56 Grand Hôpital de Charleroi Charleroi Belgium
    57 AZ Sint-Blasius Dendermonde Belgium
    58 CHU de Liège Liège Belgium
    59 AZ Glorieux Ronse Belgium
    60 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS Bologna Italy
    61 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia Italy
    62 Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Ferrara Italy
    63 Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Foggia Italy
    64 Azienda Ospedaliera Universitaria "Federico II" Napoli Italy
    65 IRCCS San Raffaele Pisana Roma Italy
    66 Hospital Universitari Vall d'Hebron Barcelona Spain
    67 Hospital Universitario Virgen de las Nieves Granada Spain
    68 Complejo Hospitalario de Jaen Jaén Spain
    69 Complejo Hospitalario Universitario A Coruña La Coruña Spain
    70 Hospital Universitario Ramon y Cajal Madrid Spain
    71 Hospital Clinico Universitario Virgen de la Victoria Málaga Spain
    72 Hospital Universitario Puerto Real Puerto Real Spain
    73 Hospital Universitario Virgen del Rocío Sevilla Spain
    74 University Hospital Basel Basel Switzerland
    75 Hôpitaux Universitaires de Genève - HUG Geneva Switzerland
    76 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland
    77 Kantonsspital St. Gallen Saint Gallen Switzerland
    78 Buckinghamshire Healthcare NHS Trust Amersham United Kingdom
    79 Bradford Royal Infirmary Bradford United Kingdom
    80 Royal Devon and Exeter Hospital (Wonford) Exeter United Kingdom
    81 Northwick Park Hospital Harrow United Kingdom
    82 Barts Health NHS Trust London United Kingdom
    83 King's College Hospital London United Kingdom
    84 Derriford Hospital Plymouth United Kingdom
    85 Whiston Hospital Rainhill United Kingdom

    Sponsors and Collaborators

    • Vifor (International) Inc.

    Investigators

    • Study Director: Udo-Michael Goehring, MD, 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:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    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 Jun 3, 2022