MedTrace Logo

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

NCT05407662 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

Interventions

OTHER

sMRA therapies

No drug will be provided to participants. Patients follow routine clinical practice/administration.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2023-06-13
Completion
2023-06-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407662 on ClinicalTrials.gov