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Trial record 1 of 1 for:    CARE-HK
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Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04864795
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Vifor Pharma ( Vifor (International) Inc. )

Study Description
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Brief 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.


Condition or disease
Heart Failure Hyperkalemia

Detailed Description:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
Single Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients by RAASi optimisation overall [ Time Frame: at 12-months following enrolment ]
    overall

  2. Percentage of patients by RAASi optimisation following hyperkalaemic events [ Time Frame: at 6-month intervals after a hyperkalaemic event ]
    RAASi

  3. 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


Secondary Outcome Measures :
  1. Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation [ Time Frame: at 12-months following enrolment ]
    RAASi

  2. 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

  3. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
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.
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.

    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.

  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:

    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.
  6. Patient judged by the Investigator to have sufficient cognitive ability to participate
  7. Signed informed consent provided.

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sandra Wächter +41 58 851 80 90 sandra.waechter@viforpharma.com

Locations
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Sponsors and Collaborators
Vifor (International) Inc.
Investigators
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Study Chair: Sandra Waechter Vifor (International) Inc.
More Information
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Responsible Party: Vifor (International) Inc.
ClinicalTrials.gov Identifier: NCT04864795    
Other Study ID Numbers: HQ-NIS-CHF-07.2020
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame:

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.

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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
Additional relevant MeSH terms:
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Heart Failure
Hyperkalemia
Heart Diseases
 Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases