Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
NCT ID: NCT04864795
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2636 participants
OBSERVATIONAL
2021-04-19
2024-08-30
Brief Summary
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The study aims to evaluate in patients at high risk of hyperkalaemia; patients treated with ACEi/ARB/ARNi, and either treated with or candidates for treatment with MRA.
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Detailed Description
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At enrolment (informed consent signed by patient), relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis.
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 and will be entered into the electronic Case Report Form (eCRF) via an electronic data capture (EDC) system. This will include treatments prescribed, routine assessments and measurements (e.g., laboratory parameters) collected at routine clinical visits, as well as hospitalisations and other relevant patient data. Protocol version 3.0, 19-Jul-2023
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
3. Patient has at least 1 record of LVEF documented in patient medical record in the 24 months prior to signature of informed consent. NOTE: If the proportion of patients with HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.
4. Patient treated with ACEi/ARB/ARNi at enrolment.
5. Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.
6. Patient at increased risk of hyperkalaemia due to one or more of the following:
1. Current hyperkalaemia (sK+ \>5.0 mEq/l) at enrolment
2. Record of documented hyperkalaemia (sK+ \>5.0 mEq/l) in the 24 months prior to signature of informed consent
3. eGFR \<45 ml/min/1.73 m2, or CKD Stage ≥3b.
7. Patient judged by the Investigator to have sufficient cognitive ability to participate.
8. Signed informed consent provided
Exclusion Criteria
2. Disease other than HF with expected survival \<1 year.
3. Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.
4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.
18 Years
ALL
No
Sponsors
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Vifor (International) Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sandra Wächter
Role: STUDY_CHAIR
Vifor International
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States
Amicis Research Center
Northridge, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Bethesda Hospital East
Boynton Beach, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Inpatient Research Clinic, LLC
Hialeah, Florida, United States
Clearwater Cardiovascular Consultants
Largo, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Southwest Florida Research, LLC
Naples, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
Clearwater Cardiovascular and Interventional Consultants
Safety Harbor, Florida, United States
Florida Cardiology P.A
Winter Park, Florida, United States
IACT Health
Columbus, Georgia, United States
Cardiology Care Clinics
Eatonton, Georgia, United States
NSC Research
Johns Creek, Georgia, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, United States
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, United States
Cardiovascular Medicine, P.C.
Davenport, Iowa, United States
Central Cardiology Associates
Elizabethtown, Kentucky, United States
Maine Health
Biddeford, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
TidalHealth Peninsula Regional Inc.
Salisbury, Maryland, United States
Ascension St. Mary's Hospital
Saginaw, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Logan Health Research
Kalispell, Montana, United States
Virtua Medical Group PA
Marlton, New Jersey, United States
Raritan Bay Primary and Cardiology Associates
Matawan, New Jersey, United States
The Heart House
Sewell, New Jersey, United States
Albany Stratton VA Medical Center
Albany, New York, United States
Capital Cardiology Associates
Albany, New York, United States
South Shore University Hospital
Bay Shore, New York, United States
Focus Clinical Research Solutions
Charlotte, North Carolina, United States
Nephrology Associates of Greater Cincinnati
Cincinnati, Ohio, United States
Rama Research LLC
Marion, Ohio, United States
The Heart and Medical Center
Durant, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
East Texas Cardiology PA
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, United States
Complete Heart Care
McKinney, Texas, United States
Baylor Scott & White Round Rock
Round Rock, Texas, United States
Baylor Scott & White Health - Temple
Temple, Texas, United States
Victoria Heart & Vascular Center
Victoria, Texas, United States
Richmond Cardiology Associates
Mechanicsville, Virginia, United States
William S. Middleton Memorial VA Hospital
Madison, Wisconsin, United States
KH St. Josef Braunau
Braunau am Inn, , Austria
LKH Universitatklinikum Graz
Graz, , Austria
Ordensklinkum Linz Elisabethinen
Linz, , Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Imed-19 privat
Vienna, , Austria
Klinik Floridsdorf
Vienna, , Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
AZ Sint-Blasius
Dendermonde, , Belgium
CHU de Liège
Liège, , Belgium
AZ Glorieux
Ronse, , Belgium
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, , Italy
A.O.U. Policlinico di Modena
Modena, , Italy
Centro Cardiologico Monzino-IRCCS
Monza, , Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
IRCCS Ospedale Policlinico San Martino
San Martino, , Italy
Azienda Servizi Sanitari 1 Triestina
Trieste, , Italy
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Juan Ramon Jimenez Hospital
Huelva, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Puerto Real
Puerto Real, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hosp. Universitari Sant Joan de Reus
Tarragona, , Spain
Kantonsspital Aarau AG
Aarau, , Switzerland
University Hospital Basel
Basel, , Switzerland
Hôpitaux Universitaires de Genève - HUG
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Buckinghamshire Healthcare NHS Trust
Amersham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
William Harvey Clinical Research Centre
London, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Whiston Hospital
Rainhill, , United Kingdom
Countries
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References
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Greene SJ, Sauer AJ, Bohm M, Bozkurt B, Butler J, Cleland JGF, Coats AJS, Desai NR, Grobbee DE, Kelepouris E, Pinto F, Rosano G, Donachie V, Fabien S, Waechter S, Crespo-Leiro MG, Hulsmann M, Kempf T, Pfister O, Pouleur AC, Saxena M, Schulz M, Volterrani M, Anker SD, Kosiborod MN. Management of patients with heart failure at high risk of hyperkalaemia: The CARE-HK in HF registry. Eur J Heart Fail. 2025 Aug 11. doi: 10.1002/ejhf.3800. Online ahead of print.
Other Identifiers
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HQ-NIS-CHF-07.2020
Identifier Type: -
Identifier Source: org_study_id
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