Institute of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland
Wroclaw, 50-556, Poland
NCT Number: NCT07781826
Heart failure is a condition that can affect a person's health and daily life. In this study, we aim to investigate how diuretic medications work and how they affect patients with heart failure.
Our main objective is to understand how the body responds to these medications and whether treatment can be adjusted to make it more effective and safer for patients.
Fluid and electrolyte imbalances are an important aspect of heart diseases. In heart failure, the body may retain excessive amounts of sodium and water, leading to symptoms of the condition. Excessive sodium retention is associated with disease severity and hormonal disturbances. One of the best ways to assess this phenomenon is to measure the amount of sodium in the urine. Although medications for heart failure are available, we do not fully understand how they affect sodium excretion. A better understanding of this mechanism may help improve and individualize treatment.
Our objectives are:
* To determine the levels of sodium and other urinary components before the administration of diuretic medication. * To assess the body's response to diuretic medication in terms of sodium excretion. * To investigate whether the body's response to diuretic medication affects the dose of medication required by the patient. * To examine how the response to diuretic medication changes over time. * To determine whether treatment intensification affects sodium retention and the volume and composition of urine following the administration of diuretic medication.
Three study visits are planned. During each visit, the first morning urine sample will be analyzed before the administration of diuretic medication. Another sample will be obtained after the medication is administered, followed by a three-hour urine collection. Blood samples will also be collected for laboratory testing.
The second visit will take place 7-14 days after the first visit, and the patient's treatment will be intensified. The third visit will take place 14 days after the second visit and will follow a procedure similar to that of the first visit.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Wroclaw, 50-556, Poland
During the second visit, neurohormonal blockade was intensified by either initiating or up-titrating treatment with eplerenone or finerenone, according to the assigned study group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During the second visit, neurohormonal blockade was intensified by either initiating or up-titrating treatment with eplerenone or finerenone, according to the assigned study group.
Time frame: After two weeks of MRA intensification treatment
Change in pre-diuretic sodium avidity, defined as the change in pre-diuretic spot urinary sodium concentration (uNa⁺) in response to MRA intensification.
Time frame: After 2 weeks of MRA intensification treatment
Change in post-diuretic sodium avidity, defined as the change in post-diuretic uNa⁺ in response to MRA intensification.
Wroclaw Medical University
Other
Acronym: uGDMT
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