Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK)
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|ClinicalTrials.gov Identifier: NCT04864795|
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : February 8, 2023
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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.
|Condition or disease|
|Heart Failure Hyperkalemia|
The study will have an enrolment period of approximately 24 months, and a follow-up period of at least 12 months and potentially up to about 60 months, resulting in a minimum study duration of 36 months, reaching a maximum of 60 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, relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis, as appropriate. After enrollment all patients will have between 12 months and up to 60 months of prospective follow-up.
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. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data. Protocol version 2.0, 07-Sep-2022
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK in HF Registry)|
|Actual Study Start Date :||April 19, 2021|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
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 12-months following enrolment ]overall
- Percentage of patients by RAASi optimisation following hyperkalaemic events [ Time Frame: at 6-month intervals after a hyperkalaemic event ]RAASi
- Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic events [ Time Frame: at 12-months following enrolment ]events
- Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation [ Time Frame: at 12-months following enrolment ]RAASi
- Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment [ Time Frame: up to 60 months following enrolment ]RAASi
- Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation [ Time Frame: at enrolment and at approximately 6-months intervals ]Kansas City Cardiomyopathy Questionnaire (KCCQ)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
Patient has at least 1 record of left ventricular ejection fraction (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 angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.
- Patient treated with or a candidate for treatment with mineralcorticoid receptor antagonist (MRA) per a relevant treatment guideline 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
- estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (CKD) stage ≥3b.
- Patient judged by the Investigator to have sufficient cognitive ability to participate
- Signed informed consent provided.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864795
|Contact: Sandra Wächter||+41 58 851 80 firstname.lastname@example.org|
|Study Chair:||Sandra Waechter||Vifor (International) Inc.|
|Responsible Party:||Vifor (International) Inc.|
|Other Study ID Numbers:||
|First Posted:||April 29, 2021 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
Statistical Analysis Plan (SAP)
Data can be requested 6 months after the primary publication for the entire prospective observation period.
Data will be available 5 years for requesting.
|Access Criteria:||A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|