Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
- Conditions
- Heart FailureHyperkalemia
- Registration Number
- NCT04864795
- Lead Sponsor
- Vifor (International) Inc.
- 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 adherence to RAASi treatment recommendations, according to the AHA/ACC and ESC guidelines. Objectives relating to patiromer effectiveness will only be evaluated if a sufficient number of patients are available.
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.
- Detailed Description
The study will have an enrolment period of approximately 24 months, and each patient will be followed prospectively for at least 6 months. Each patient is expected to contribute to the study data collection until study end or until premature discontinuation, whichever occurs first (i.e., due to death, withdrawal of consent, or lost to follow-up).
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2636
-
Adult aged ≥18 years at enrolment.
-
Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
-
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.
-
Patient treated with ACEi/ARB/ARNi at enrolment.
-
Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.
-
Patient at increased risk of hyperkalaemia due to one or more of the following:
- Current hyperkalaemia (sK+ >5.0 mEq/l) at enrolment
- Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior to signature of informed consent
- eGFR <45 ml/min/1.73 m2, or CKD Stage ≥3b.
-
Patient judged by the Investigator to have sufficient cognitive ability to participate.
-
Signed informed consent provided
- Patient on renal replacement therapy or mechanical circulatory support.
- Disease other than HF with expected survival <1 year.
- Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.
- Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients by RAASi optimisation at 6-months intervals overall
Percentage of patients by RAASi dose modification following hyperkalaemic episodes at 6-month intervals after a hyperkalaemic episode RAASi
Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic at 6-months following enrolment episodes
- Secondary Outcome Measures
Name Time Method Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment up to 6 months following enrolment RAASi
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)
Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation at 6-months following enrolment RAASi
Trial Locations
- Locations (115)
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Clearwater Cardiovascular and Interventional Consultants
🇺🇸Safety Harbor, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Logan Health Research
🇺🇸Kalispell, Montana, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Scott & White Round Rock
🇺🇸Round Rock, Texas, United States
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Bethesda Hospital East
🇺🇸Boynton Beach, Florida, United States
Inpatient Research Clinic, LLC
🇺🇸Hialeah, Florida, United States
Peace River Cardiovascular Center
🇺🇸Port Charlotte, Florida, United States
Florida Cardiology P.A
🇺🇸Winter Park, Florida, United States
IACT Health
🇺🇸Columbus, 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
TidalHealth Peninsula Regional Inc.
🇺🇸Salisbury, Maryland, United States
Klinik Floridsdorf
🇦🇹Wien, Austria
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hosp. Universitari Sant Joan de Reus
🇪🇸Tarragona, Spain
Derriford Hospital
🇬🇧Plymouth, United Kingdom
D&H National Research Centers
🇺🇸Miami, Florida, United States
UC San Diego Sulpizio Cardiovascular Center
🇺🇸La Jolla, California, United States
Amicis Research Center
🇺🇸Northridge, California, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Barts Health NHS Trust
🇬🇧London, United Kingdom
Maine Health
🇺🇸Biddeford, Maine, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
🇧🇪Brussels, Belgium
AZ Sint-Blasius
🇧🇪Dendermonde, Belgium
CHU de Liège
🇧🇪Liège, Belgium
The Heart House
🇺🇸Sewell, New Jersey, United States
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Wien, Austria
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Clearwater Cardiovascular Consultants
🇺🇸Largo, Florida, United States
IRCCS San Raffaele Pisana
🇮🇹Roma, Italy
LKH Universitatklinikum Graz
🇦🇹Graz, Austria
Centro Cardiologico Monzino-IRCCS
🇮🇹Monza, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹San Martino, Italy
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
NSC Research
🇺🇸Johns Creek, Georgia, United States
Southwest Florida Research, LLC
🇺🇸Naples, Florida, United States
Cardiology Care Clinics
🇺🇸Eatonton, Georgia, United States
Raritan Bay Primary and Cardiology Associates
🇺🇸Matawan, New Jersey, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
St. Louis Heart and Vascular
🇺🇸Bridgeton, Missouri, United States
Virtua Medical Group PA
🇺🇸Marlton, New Jersey, United States
Focus Clinical Research Solutions
🇺🇸Charlotte, North Carolina, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
Albany Stratton VA Medical Center
🇺🇸Albany, New York, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
Nephrology Associates of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Rama Research LLC
🇺🇸Marion, Ohio, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
The Heart and Medical Center
🇺🇸Durant, Oklahoma, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
East Texas Cardiology PA
🇺🇸Houston, Texas, United States
Texas Cardiology Associates of Houston
🇺🇸Kingwood, Texas, United States
Complete Heart Care
🇺🇸McKinney, Texas, United States
Richmond Cardiology Associates
🇺🇸Mechanicsville, Virginia, United States
Victoria Heart & Vascular Center
🇺🇸Victoria, Texas, United States
KH St. Josef Braunau
🇦🇹Braunau Am Inn, Austria
Ordensklinkum Linz Elisabethinen
🇦🇹Linz, Austria
Imed-19 privat
🇦🇹Wien, Austria
AZ Glorieux
🇧🇪Ronse, Belgium
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
🇮🇹Brescia, Italy
Grand Hôpital de Charleroi
🇧🇪Charleroi, Belgium
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
🇮🇹Foggia, Italy
Azienda Ospedaliera Universitaria "Federico II"
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
🇮🇹Ferrara, Italy
A.O.U. Policlinico di Modena
🇮🇹Modena, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Azienda Servizi Sanitari 1 Triestina
🇮🇹Triest, Italy
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Juan Ramon Jimenez Hospital
🇪🇸Huelva, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Complejo Hospitalario de Jaen
🇪🇸Jaén, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Puerto Real
🇪🇸Puerto Real, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, 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
🇨🇭Luzern, Switzerland
Kantonsspital St. Gallen
🇨🇭Saint Gallen, Switzerland
Buckinghamshire Healthcare NHS Trust
🇬🇧Amersham, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Whiston Hospital
🇬🇧Rainhill, United Kingdom
William Harvey Clinical Research Centre
🇬🇧London, United Kingdom
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
William S. Middleton Memorial VA Hospital
🇺🇸Madison, Wisconsin, United States
Ascension St. Mary's Hospital
🇺🇸Saginaw, Michigan, United States
Baylor Scott & White Health - Temple
🇺🇸Temple, Texas, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom