Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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 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.

Official Title

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

Details

The study will have a 24-month enrolment period, followed by a 24-month follow-up period, resulting in a total study duration of 48 months. 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 24 months and 48 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.

Keywords

Heart Failure Hyperkalemia

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
  2. 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.
  3. Patient treated with angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.
  4. Patient treated with or a candidate for treatment with mineralcorticoid receptor antagonist (MRA) per a relevant treatment guideline at enrolment.
  5. Patient at increased risk of hyperkalaemia due to one or more of the following:
  6. Current hyperkalaemia (sK+ >5.0 mEq/L) at enrolment
  7. Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior to signature of informed consent
  8. estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (CKD) stage ≥3b.
  9. Patient judged by the Investigator to have sufficient cognitive ability to participate

You CAN'T join if...

  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.
  4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.

Locations

  • UC San Diego Sulpizio Cardiovascular Center accepting new patients
    La Jolla California 92037 United States
  • Amicis Research Center accepting new patients
    Northridge California 91324 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vifor (International) Inc.
ID
NCT04864795
Study Type
Observational [Patient Registry]
Participants
Expecting 5000 study participants
Last Updated