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NCT04864795Completed

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2636 (actual)
First submitted
6 Apr 2021
Start date
19 Apr 2021
Primary completion date
29 Feb 2024
Lead sponsor
Vifor (International) Inc.
NCT number
NCT04864795

What you commit to

  • Study type: Observational
  • Participants enrolled: 2636
  • From 19 Apr 2021 to the primary completion date, 29 Feb 2024
  • 116 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient on renal replacement therapy or mechanical circulatory support.

Other illness

  • Disease other than HF with expected survival \<1 year.
  • Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.

Other

  • Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (116)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KH St. Josef Braunau
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Braunau am InnAustriaUnknown status
LKH Universitatklinikum Graz
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GrazAustriaUnknown status
Ordensklinkum Linz Elisabethinen
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LinzAustriaUnknown status
Klinik Floridsdorf
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ViennaAustriaUnknown status
Imed-19 privat
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ViennaAustriaUnknown status
Allgemeines Krankenhaus der Stadt Wien
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ViennaAustriaUnknown status
Cliniques Universitaires de Bruxelles Hopital Erasme
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BrusselsBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumUnknown status
AZ Sint-Blasius
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DendermondeBelgiumUnknown status
CHU de Liège
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LiègeBelgiumUnknown status
az Glorieux
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RonseBelgiumUnknown status
Kantonsspital Aarau AG
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AarauSwitzerlandUnknown status
University Hospital Basel
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BaselSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG)
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GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire Vaudois
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LausanneSwitzerlandUnknown status
Luzerner Kantonsspital
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LucerneSwitzerlandUnknown status
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandUnknown status
Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainUnknown status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitari de Bellvitge
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Juan Ramón Jimenez Hospital
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HuelvaSpainUnknown status
Complejo Hospitalario de Jaen
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JaénSpainUnknown status
Hospital Universitario de Gran Canaria Dr Negrín
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitario Severo Ochoa
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LeganésSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario Infanta Leonor
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MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Clínico San Carlos
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainUnknown status
Hospital Clinico Universitario Virgen de La Victoria
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MálagaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Complejo Hospitalario de Navarra
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PamplonaSpainUnknown status
Hospital Universitario Puerto Real
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Puerto RealSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hosp. Universitari Sant Joan de Reus
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TarragonaSpainUnknown status
Buckinghamshire Healthcare Nhs Trust
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AmershamUnited KingdomUnknown status
Bradford Royal Infirmary
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BradfordUnited KingdomUnknown status
Royal Devon and Exeter Hospital (Wonford)
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ExeterUnited KingdomUnknown status
Northwick Park Hospital
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HarrowUnited KingdomUnknown status
Royal Liverpool University Hospital
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LiverpoolUnited KingdomUnknown status
William Harvey Clinical Research Centre
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LondonUnited KingdomUnknown status
King's College Hospital
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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NewcastleUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Whiston Hospital
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RainhillUnited KingdomUnknown status
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Irccs
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BolognaItalyUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
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BresciaItalyUnknown status
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
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FerraraItalyUnknown status
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
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FoggiaItalyUnknown status
A.O.U. Policlinico di Modena
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ModenaItalyUnknown status
Centro Cardiologico Monzino-IRCCS
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MonzaItalyUnknown status
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyUnknown status
Azienda Ospedaliero Universitaria Pisana
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PisaItalyUnknown status
Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
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Reggio EmiliaItalyUnknown status
IRCCS San Raffaele Pisana
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RomaItalyUnknown status
IRCCS Ospedale Policlinico San Martino
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San MartinoItalyUnknown status
Azienda Servizi Sanitari 1 Triestina
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TriesteItalyUnknown status
Albany Stratton VA Medical Center
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AlbanyUnited StatesUnknown status
Capital Cardiology Associates
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AlbanyUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
South Shore University Hospital
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Bay ShoreUnited StatesUnknown status
Maine Health
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BiddefordUnited StatesUnknown status
Bethesda Hospital East
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Boynton BeachUnited StatesUnknown status
Bridgeport Hospital
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BridgeportUnited StatesUnknown status
St. Louis Heart and Vascular
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BridgetonUnited StatesUnknown status
Capital Area Research, LLC
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Camp HillUnited StatesUnknown status
Focus Clinical Research Solutions
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CharlotteUnited StatesUnknown status
Nephrology Associates of Greater Cincinnati
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CincinnatiUnited StatesUnknown status
Clearwater Cardiovascular Consultants
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ClearwaterUnited StatesUnknown status
Innovative Research of West Florida, Inc.
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ClearwaterUnited StatesUnknown status
IACT Health
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ColumbusUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Cardiovascular Medicine, P.C.
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DavenportUnited StatesUnknown status
The Heart and Medical Center
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DurantUnited StatesUnknown status
Cardiology Care Clinics
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EatontonUnited StatesUnknown status
Central Cardiology Associates
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ElizabethtownUnited StatesUnknown status
Chicago Medical Research LLC
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Hazel CrestUnited StatesUnknown status
Inpatient Research Clinic, LLC
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HialeahUnited StatesUnknown status
Biopharma Informatic, LLC
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HoustonUnited StatesUnknown status
East Texas Cardiology PA
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HoustonUnited StatesUnknown status
NSC Research
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Johns CreekUnited StatesUnknown status
Logan Health Research
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KalispellUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Texas Cardiology Associates of Houston
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KingwoodUnited StatesUnknown status
UC San Diego Sulpizio Cardiovascular Center
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La JollaUnited StatesUnknown status
Clearwater Cardiovascular Consultants
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LargoUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
William S. Middleton Memorial VA Hospital
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MadisonUnited StatesUnknown status
Rama Research LLC
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MarionUnited StatesUnknown status
Virtua Medical Group PA
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MarltonUnited StatesUnknown status
Raritan Bay Primary and Cardiology Associates
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MatawanUnited StatesUnknown status
Complete Heart Care
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McKinneyUnited StatesUnknown status
Richmond Cardiology Associates
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MechanicsvilleUnited StatesUnknown status
D&H National Research Centers
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MiamiUnited StatesUnknown status
Minneapolis Heart Institute Foundation
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MinneapolisUnited StatesUnknown status
Southwest Florida Research, LLC
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NaplesUnited StatesUnknown status
Amicis Research Center
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NorthridgeUnited StatesUnknown status
UPMC Presbyterian Hospital
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PittsburghUnited StatesUnknown status
Peace River Cardiovascular Center
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Port CharlotteUnited StatesUnknown status
Baylor Scott & White - Round Rock
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Round RockUnited StatesUnknown status
Clearwater Cardiovascular and Interventional Consultants
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Safety HarborUnited StatesUnknown status
Ascension St. Mary's Hospital
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SaginawUnited StatesUnknown status
TidalHealth Peninsula Regional, Inc.
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SalisburyUnited StatesUnknown status
The Heart House
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SewellUnited StatesUnknown status
Prairie Cardiovascular Consultants, Ltd.
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SpringfieldUnited StatesUnknown status
St Louis University
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St LouisUnited StatesUnknown status
Baylor Scott & White Health - Temple
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TempleUnited StatesUnknown status
Victoria Heart & Vascular Center
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VictoriaUnited StatesUnknown status
Florida Cardiology P.A
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.