For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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.

  1. Patient treated with angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.
  2. 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:

  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. estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (CKD) stage ≥3b.
  4. Patient judged by the Investigator to have sufficient cognitive ability to participate
  5. Signed informed consent provided.

EXCLUSION CRITERIA

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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Heart Failure,Hyperkalemia

Age (in years)

18+

Participants needed

2000

Est. Completion Date

May 31, 2025

Treatment type

Observational [Patient Registry]


Sponsor

Vifor Pharma

ClinicalTrials.gov identifier

NCT04864795

Study number

HQ-NIS-CHF-07.2020

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