Heart Failure Clinical Trial

Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia

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.

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Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 is for people with:

Heart Failure

Estimated Enrollment:

2636

Study ID:

NCT04864795

Recruitment Status:

Active, not recruiting

Sponsor:

Vifor (International) Inc.

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There are 53 Locations for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla California, 92037, United States
Amicis Research Center
Northridge California, 91324, United States
Bridgeport Hospital
Bridgeport Connecticut, 06610, United States
Bethesda Hospital East
Boynton Beach Florida, 33425, United States
Clearwater Cardiovascular Consultants
Clearwater Florida, 33756, United States
Innovative Research of West Florida, Inc.
Clearwater Florida, 33756, United States
Inpatient Research Clinic, LLC
Hialeah Florida, 33013, United States
Clearwater Cardiovascular Consultants
Largo Florida, 33777, United States
D&H National Research Centers
Miami Florida, 33173, United States
Southwest Florida Research, LLC
Naples Florida, 34102, United States
Peace River Cardiovascular Center
Port Charlotte Florida, 33952, United States
Clearwater Cardiovascular and Interventional Consultants
Safety Harbor Florida, 32695, United States
Florida Cardiology P.A
Winter Park Florida, 32792, United States
IACT Health
Columbus Georgia, 31904, United States
Cardiology Care Clinics
Eatonton Georgia, 31024, United States
NSC Research
Johns Creek Georgia, 30024, United States
Chicago Medical Research, LLC
Hazel Crest Illinois, 60429, United States
Prairie Cardiovascular Consultants, Ltd.
Springfield Illinois, 62701, United States
Cardiovascular Medicine, P.C.
Davenport Iowa, 52803, United States
Central Cardiology Associates
Elizabethtown Kentucky, 42701, United States
Maine Health
Biddeford Maine, 04005, United States
Johns Hopkins University
Baltimore Maryland, 21218, United States
TidalHealth Peninsula Regional Inc.
Salisbury Maryland, 21801, United States
Ascension St. Mary's Hospital
Saginaw Michigan, 48601, United States
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States
St. Louis Heart and Vascular
Bridgeton Missouri, 63044, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
St. Louis University
Saint Louis Missouri, 63104, United States
Logan Health Research
Kalispell Montana, 59901, United States
Virtua Medical Group PA
Marlton New Jersey, 08053, United States
Raritan Bay Primary and Cardiology Associates
Matawan New Jersey, 07747, United States
The Heart House
Sewell New Jersey, 08080, United States
Albany Stratton VA Medical Center
Albany New York, 12208, United States
Capital Cardiology Associates
Albany New York, 12211, United States
South Shore University Hospital
Bay Shore New York, 11706, United States
Focus Clinical Research Solutions
Charlotte North Carolina, 28204, United States
Nephrology Associates of Greater Cincinnati
Cincinnati Ohio, 45236, United States
Rama Research LLC
Marion Ohio, 43302, United States
The Heart and Medical Center
Durant Oklahoma, 74701, United States
Capital Area Research, LLC
Camp Hill Pennsylvania, 17011, United States
UPMC Presbyterian Hospital
Pittsburgh Pennsylvania, 15213, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
East Texas Cardiology PA
Houston Texas, 77002, United States
Biopharma Informatic, LLC
Houston Texas, 77084, United States
Texas Cardiology Associates of Houston
Kingwood Texas, 77339, United States
Complete Heart Care
McKinney Texas, 75071, United States
Baylor Scott & White Round Rock
Round Rock Texas, 78665, United States
Baylor Scott & White Health - Temple
Temple Texas, 76508, United States
Victoria Heart & Vascular Center
Victoria Texas, 77901, United States
Richmond Cardiology Associates
Mechanicsville Virginia, 23116, United States
William S. Middleton Memorial VA Hospital
Madison Wisconsin, 53705, 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
Wien , , Austria
Imed-19 privat
Wien , , Austria
Klinik Floridsdorf
Wien , , Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels , , Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , , 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
Triest , , Italy
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Hospital Universitario Severo Ochoa
Leganés Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, , Spain
Complejo Hospitalario de Navarra
Pamplona Navarra, , 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
Complejo Hospitalario Universitario A Coruña
La Coruña , , 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
Sevilla , , Spain
Hospital Universitario Virgen Macarena
Sevilla , , 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
Luzern , , Switzerland
Kantonsspital St. Gallen
Saint 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 , NE1 4, United Kingdom
Derriford Hospital
Plymouth , , United Kingdom
Whiston Hospital
Rainhill , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2636

Study ID:

NCT04864795

Recruitment Status:

Active, not recruiting

Sponsor:


Vifor (International) Inc.

How clear is this clinincal trial information?

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