A Study Using Surveys to Learn More About Treatment With Steroidal Mineralocorticoid Receptor Antagonists, How They Are Used, What Side Effects They Have, and How Satisfied People Who Receive Them Are in the US

Heart Failure Clinical Trial

Official title:

REal-world Use of steroidaL mIneralocorticoid reCeptor Antagonists - the RELICS Study - Patient Survey (PS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407662
• Other study ID #: 22114
• Status: Completed
• Start date: November 2, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: September 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study in which patients with chronic kidney diseases (CKD), type 2 diabetes (T2D) or heart failure (HF) who are current or past users of sMRA therapies are studied. sMRA stands for steroidal mineralocorticoid receptor antagonists.

CKD is a long-term, progressive decrease in the kidneys' ability to work properly.

Type 2 diabetes is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well resulting in high blood sugar levels.

HF is a condition in which the heart does not pump blood as well as it should.

The renin-angiotensin-aldosterone system (RAAS) is a hormone system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes (like salt) in the blood. The RAAS has been a treatment target of heart and kidney diseases for decades. One of these classes of medications is called mineralocorticoid receptor (MR) antagonists (MRAs). MRAs work to directly block the action of a hormone called aldosterone. Aldosterone is produced naturally by the adrenal glands, and it can increase the blood volume and blood pressure. Using MRAs therapies can help prevent strokes, heart attacks and kidney problems.

Spironolactone was the first available MRA in the US with its approval in 1960. Eplerenone is another MRA which has been available since 2002. Both spironolactone and eplerenone are known as steroidal MRA (sMRA) due to their chemical structures.

The main purpose of this study is to collect more data on the characteristics of patients who are taking sMRA currently and those who have discontinued sMRA therapy in the past 12 months.

To do this, patients who have received sMRA in the most recent 12 months will be invited to participate in the study and asked to complete surveys if they agree to join the study. Patients will be found from administrative claims in a database called HealthCore Integrated Research Database (HIRD).

And the other purposes of the study are to learn more about:

• the indications for sMRA therapy

• the frequency and symptoms of reported side effects of sMRA treatment

• the treatment satisfaction and effectiveness as well as potential reasons for treatment continuation/discontinuation of sMRA therapies

Besides this data collection, no further tests or examinations are planned in this study.

The participants will receive their treatments as prescribed by their doctors during routine practice according to the approved product information.

Researchers will look at the health information from adult men and women in the US only if applicable who are current/past users of sMRA therapies with diagnosis of CKD or T2D or HF, consent to participate in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently active with commercial or Medicare Advantage health insurance (both medical and pharmacy benefits) at the time the patient sample is identified

• =1 pharmacy claim for a sMRA therapy (spironolactone or eplerenone) in the most recent 12-months of claims data

• =1 inpatient or =2 outpatient medical claims with an International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification (ICD-9/10-CM) diagnosis code for CKD, T2D or HF going back to 1 Jan 2006

• Age =18 years at the end of the patient identification period

• Has email and/or mailing address

• Consent to participate in the survey

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Other:
• sMRA therapies
No drug will be provided to participants. Patients follow routine clinical practice/administration.

Locations

Country	Name	City	State
United States	Many Locations	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening questions - to verify the participant's basic information and current health plan status and validate their current or recent use of sMRA therapy	sMRA stands for steroidal mineralocorticoid receptor antagonists.	Up to 12 months
Primary	Condition history - to confirm the diagnosis of CKD, T2D, or HF, determine the age at condition diagnosis, and the type of physician who currently manages/treats condition		Up to 12 months
Primary	sMRA discontinuer questions - questions for patients who have discontinued sMRA therapies, including duration of use, how long ago discontinued and most recent dose		Up to 12 months
Primary	sMRA continuing user questions - questions for patients who are current sMRA users including current sMRA therapy, how long used and most recent dose		Up to 12 months
Primary	Clinical characteristics		Up to 12 months
Primary	Demographic characteristics		Up to 12 months
Primary	Claims-based patient characteristics		Up to 12 months
Primary	Baseline comorbid conditions of interest		Up to 12 months
Primary	Baseline sMRA adherence and persistence		Up to 12 months
Primary	Baseline all-cause healthcare resource utilization by place of service		Up to 12 months
Primary	Baseline all-cause healthcare costs by place of service		Up to 12 months
Secondary	sMRA discontinuer questions - targeted past medical history (indications for sMRA therapy) , reasons for choosing/discontinuing to sMRA therapy		Up to 12 months
Secondary	sMRA continuing user questions - targeted past medical history (indications for sMRA therapy), reasons for choosing/continuing to use current sMRA		Up to 12 months
Secondary	sMRA discontinuer questions - occurrence of sMRA side effects		Up to 12 months
Secondary	sMRA continuing user questions - occurrence of sMRA side effects		Up to 12 months
Secondary	sMRA discontinuer questions - reasons for discontinuing sMRA therapy, perceived effectiveness and overall satisfaction with the sMRA therapy		Up to 12 months
Secondary	sMRA continuing user questions - Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM v1.4) - validated PROM the evaluates patients' perception of sMRA treatment effectiveness, convenience, and overall satisfaction		Up to 12 months

External Links

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