[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+41 58 851 80 00

Email address

henrik.schou@viforpharma.com

Condition

Heart Failure,Hyperkalemia

Treatment type

Observational [Patient Registry]

Sponsor

Vifor Pharma

ClinicalTrials.gov identifier

NCT04864795

Study number

HQ-NIS-CHF-07.2020

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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.

Who can take part?

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

Inclusion criteria

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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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