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

Heart Failure Clinical Trial

— CARE-HK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864795
• Other study ID #: HQ-NIS-CHF-07.2020
• Status: Recruiting
• Start date: April 19, 2021
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Vifor Pharma
• Contact: Sandra Wächter
• Phone: +41 58 851 80 90
• Email: sandra.waechter[@]viforpharma.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult aged =18 years at enrolment.

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:

1. Patient on renal replacement therapy or mechanical circulatory support.

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.

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia

Locations

Country	Name	City	State
Austria	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
Belgium	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
Italy	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
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 Severo Ochoa	Leganés	Madrid
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 Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
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
Switzerland	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
United Kingdom	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 States	Albany Stratton VA Medical Center	Albany	New York
United States	Capital Cardiology Associates	Albany	New York
United States	Johns Hopkins University	Baltimore	Maryland
United States	South Shore University Hospital	Bay Shore	New York
United States	Maine Health	Biddeford	Maine
United States	Bethesda Hospital East	Boynton Beach	Florida
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	St. Louis Heart and Vascular	Bridgeton	Missouri
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Focus Clinical Research Solutions	Charlotte	North Carolina
United States	Nephrology Associates of Greater Cincinnati	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	IACT Health	Columbus	Georgia
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Cardiovascular Medicine, P.C.	Davenport	Iowa
United States	The Heart and Medical Center	Durant	Oklahoma
United States	Cardiology Care Clinics	Eatonton	Georgia
United States	Central Cardiology Associates	Elizabethtown	Kentucky
United States	Chicago Medical Research, LLC	Hazel Crest	Illinois
United States	Inpatient Research Clinic, LLC	Hialeah	Florida
United States	Biopharma Informatic, LLC	Houston	Texas
United States	East Texas Cardiology PA	Houston	Texas
United States	NSC Research	Johns Creek	Georgia
United States	Logan Health Research	Kalispell	Montana
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Texas Cardiology Associates of Houston	Kingwood	Texas
United States	UC San Diego Sulpizio Cardiovascular Center	La Jolla	California
United States	Clearwater Cardiovascular Consultants	Largo	Florida
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	William S. Middleton Memorial VA Hospital	Madison	Wisconsin
United States	Rama Research LLC	Marion	Ohio
United States	Virtua Medical Group PA	Marlton	New Jersey
United States	Raritan Bay Primary and Cardiology Associates	Matawan	New Jersey
United States	Complete Heart Care	McKinney	Texas
United States	Richmond Cardiology Associates	Mechanicsville	Virginia
United States	D&H National Research Centers	Miami	Florida
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Southwest Florida Research, LLC	Naples	Florida
United States	Amicis Research Center	Northridge	California
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Peace River Cardiovascular Center	Port Charlotte	Florida
United States	Baylor Scott & White Round Rock	Round Rock	Texas
United States	Clearwater Cardiovascular and Interventional Consultants	Safety Harbor	Florida
United States	Ascension St. Mary's Hospital	Saginaw	Michigan
United States	St. Louis University	Saint Louis	Missouri
United States	TidalHealth Peninsula Regional Inc.	Salisbury	Maryland
United States	The Heart House	Sewell	New Jersey
United States	Prairie Cardiovascular Consultants, Ltd.	Springfield	Illinois
United States	Baylor Scott & White Health - Temple	Temple	Texas
United States	Victoria Heart & Vascular Center	Victoria	Texas
United States	Florida Cardiology P.A	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vifor (International) Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients by RAASi optimisation	overall	at 6-months intervals
Primary	Percentage of patients by RAASi dose modification following hyperkalaemic episodes	RAASi	at 6-month intervals after a hyperkalaemic episode
Primary	Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic	episodes	at 6-months following enrolment
Secondary	Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation	RAASi	at 6-months following enrolment
Secondary	Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment	RAASi	up to 6 months following enrolment
Secondary	Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation	Kansas City Cardiomyopathy Questionnaire (KCCQ)	at enrolment and at approximately 6-months intervals