An observational study in Heart Failure and Hyperkalemia, sponsored by Vifor (International) Inc.. Completed at 116 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Vifor (International) Inc. · Observational
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.
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
To the extent possible, representative sites (e.g., cardiologists and nephrologists) reflective of the treatment patterns within each country will be recruited. All patients treated for chronic HF during the enrolment period will be assessed for eligibility, and all eligible patients will be consecutively proposed to enrol in the study as they present for a routine clinical visit (in-person or virtual visits) in order to avoid potential selection bias.
Patient at increased risk of hyperkalaemia due to one or more of the following:
Exclusion Criteria:
Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data.
Percentage of patients by RAASi optimisation
overall
Time frame: at 6-months intervals
Percentage of patients by RAASi dose modification following hyperkalaemic episodes
RAASi
Time frame: at 6-month intervals after a hyperkalaemic episode
Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic
episodes
Time frame: at 6-months following enrolment
Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation
RAASi
Time frame: at 6-months following enrolment
Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment
RAASi
Time frame: up to 6 months following enrolment
Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: at enrolment and at approximately 6-months intervals
Showing the first 100 of 116 sites across 7 countries.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Vifor (International) Inc.