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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey on users of sMRA therapies | sMRA stands for steroidal mineralocorticoid receptor antagonist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sMRA therapies | Other | No drug will be provided to participants. Patients follow routine clinical practice/administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | |
| 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 | |
| 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 | |
| Clinical characteristics | Up to 12 months | |
| Demographic characteristics | Up to 12 months | |
| Claims-based patient characteristics | Up to 12 months | |
| Baseline comorbid conditions of interest | Up to 12 months | |
| Baseline sMRA adherence and persistence | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| sMRA discontinuer questions - targeted past medical history (indications for sMRA therapy) , reasons for choosing/discontinuing to sMRA therapy | Up to 12 months | |
| sMRA continuing user questions - targeted past medical history (indications for sMRA therapy), reasons for choosing/continuing to use current sMRA |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Patients who are current/past users of sMRA therapies who were diagnosed with chronic kidney disease, type 2 diabetes mellitus or heart failure, consent to participate in the study and have a valid survey.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Whippany | New Jersey | 07981 | United States |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Baseline all-cause healthcare resource utilization by place of service | Up to 12 months |
| Baseline all-cause healthcare costs by place of service | Up to 12 months |
| Up to 12 months |
| sMRA discontinuer questions - occurrence of sMRA side effects | Up to 12 months |
| sMRA continuing user questions - occurrence of sMRA side effects | Up to 12 months |
| sMRA discontinuer questions - reasons for discontinuing sMRA therapy, perceived effectiveness and overall satisfaction with the sMRA therapy | Up to 12 months |
| 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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