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.
- Diseases
- Heart failure
- 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
Sites (116)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KH St. Josef Braunau Coordinator of this site? Confirm its status | Braunau am Inn | Austria | Unknown status |
| LKH Universitatklinikum Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Ordensklinkum Linz Elisabethinen Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Imed-19 privat Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Allgemeines Krankenhaus der Stadt Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Cliniques Universitaires de Bruxelles Hopital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| AZ Sint-Blasius Coordinator of this site? Confirm its status | Dendermonde | Belgium | Unknown status |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| az Glorieux Coordinator of this site? Confirm its status | Ronse | Belgium | Unknown status |
| Kantonsspital Aarau AG Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève (HUG) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Juan Ramón Jimenez Hospital Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Complejo Hospitalario de Jaen Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario Severo Ochoa Coordinator of this site? Confirm its status | Leganés | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Complejo Hospitalario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario Puerto Real Coordinator of this site? Confirm its status | Puerto Real | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Universitari Sant Joan de Reus Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Buckinghamshire Healthcare Nhs Trust Coordinator of this site? Confirm its status | Amersham | United Kingdom | Unknown status |
| Bradford Royal Infirmary Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Royal Devon and Exeter Hospital (Wonford) Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Northwick Park Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Unknown status |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| William Harvey Clinical Research Centre Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Whiston Hospital Coordinator of this site? Confirm its status | Rainhill | United Kingdom | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Irccs Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| A.O.U. Policlinico di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Centro Cardiologico Monzino-IRCCS Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| IRCCS San Raffaele Pisana Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | San Martino | Italy | Unknown status |
| Azienda Servizi Sanitari 1 Triestina Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
| Albany Stratton VA Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Capital Cardiology Associates Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| South Shore University Hospital Coordinator of this site? Confirm its status | Bay Shore | United States | Unknown status |
| Maine Health Coordinator of this site? Confirm its status | Biddeford | United States | Unknown status |
| Bethesda Hospital East Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
| Bridgeport Hospital Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| St. Louis Heart and Vascular Coordinator of this site? Confirm its status | Bridgeton | United States | Unknown status |
| Capital Area Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Unknown status |
| Focus Clinical Research Solutions Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Nephrology Associates of Greater Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Innovative Research of West Florida, Inc. Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| IACT Health Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Cardiovascular Medicine, P.C. Coordinator of this site? Confirm its status | Davenport | United States | Unknown status |
| The Heart and Medical Center Coordinator of this site? Confirm its status | Durant | United States | Unknown status |
| Cardiology Care Clinics Coordinator of this site? Confirm its status | Eatonton | United States | Unknown status |
| Central Cardiology Associates Coordinator of this site? Confirm its status | Elizabethtown | United States | Unknown status |
| Chicago Medical Research LLC Coordinator of this site? Confirm its status | Hazel Crest | United States | Unknown status |
| Inpatient Research Clinic, LLC Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| East Texas Cardiology PA Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| NSC Research Coordinator of this site? Confirm its status | Johns Creek | United States | Unknown status |
| Logan Health Research Coordinator of this site? Confirm its status | Kalispell | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Texas Cardiology Associates of Houston Coordinator of this site? Confirm its status | Kingwood | United States | Unknown status |
| UC San Diego Sulpizio Cardiovascular Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Largo | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| William S. Middleton Memorial VA Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Rama Research LLC Coordinator of this site? Confirm its status | Marion | United States | Unknown status |
| Virtua Medical Group PA Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
| Raritan Bay Primary and Cardiology Associates Coordinator of this site? Confirm its status | Matawan | United States | Unknown status |
| Complete Heart Care Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Richmond Cardiology Associates Coordinator of this site? Confirm its status | Mechanicsville | United States | Unknown status |
| D&H National Research Centers Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Southwest Florida Research, LLC Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Amicis Research Center Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| UPMC Presbyterian Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Peace River Cardiovascular Center Coordinator of this site? Confirm its status | Port Charlotte | United States | Unknown status |
| Baylor Scott & White - Round Rock Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Clearwater Cardiovascular and Interventional Consultants Coordinator of this site? Confirm its status | Safety Harbor | United States | Unknown status |
| Ascension St. Mary's Hospital Coordinator of this site? Confirm its status | Saginaw | United States | Unknown status |
| TidalHealth Peninsula Regional, Inc. Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| The Heart House Coordinator of this site? Confirm its status | Sewell | United States | Unknown status |
| Prairie Cardiovascular Consultants, Ltd. Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| St Louis University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Baylor Scott & White Health - Temple Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| Victoria Heart & Vascular Center Coordinator of this site? Confirm its status | Victoria | United States | Unknown status |
| Florida Cardiology P.A Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.