Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
NCT03888066
Cardiovascular Diseases, Chronic Disease
Alexander City, Alabama, United States
View Trial DetailsNCT Number: NCT05408039
This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care.
The primary objective:
• Describe HK management decisions, their rationale and treatment expectations.
The secondary objective:
• Describe baseline characteristics and longitudinal clinical variables in patients with HK.
The exploratory objective:
• Describe patient awareness and satisfaction with their HK treatment management across the study period.
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Notify Me18 year–130 year
All sexes
Observational
Research Site, Bad Krozingen, Germany
This study is a multinational, observational, prospective, longitudinal, cohort study that will include primary and secondary data collection. Secondary data, collected as per routine clinical practice will be extracted from electronic health records (EHR) and manually entered into the electronic case report form (eCRF). Primary data will be collected directly from patients and Health Care Providers (HCPs). Prospective data collection will be performed for a period of 12 months and will include data collection at baseline, that is, the date of enrollment, and at 3-, 6-, 9-, and 12-months following baseline. The data collection timepoints in this study is irrespective of when the patient's medical visits are scheduled. There are no study specific patient visits mandated by protocol and study may be fully virtual.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients meeting all the following inclusion criteria will be eligible for inclusion into the study:
(*enrollment in study is defined as the date of Informed consent and confirmation of study eligibility, whichever occurs later).
Patients will be excluded from the study if they meet any of the following criteria:
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Time frame: Up to 12 months following enrolment.
Functional Assessment of Chronic Illness Therapy Treatment Satisfaction-General (FACIT-TS-G) and bespoke questions on dietary recommendations.
AstraZeneca
Industry
A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia
Acronym: TRACK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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