Heart Failure
Conditions
Keywords
hypervolemia, renal failure,, Diuretic treatment, heart failure
Brief summary
It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). This prospective study aims to assess the effects of diuretic treatment in systolic HF patients who have no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). The study compares the outcomes of patients receiving bioimpedance-guided diuretic therapy to maintain negative hydration versus those followed without diuretic therapy over a 1-year period.
Detailed description
Background and Objectives It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). The primary objective of this prospective study is to assess the effects of diuretic treatment in patients with systolic HF who exhibit no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). Furthermore, the study aims to compare the clinical outcomes of these patients with a control group not receiving diuretic treatment. Methods This prospective study includes adult patients with systolic HF. The patients are assigned into two groups: Negative Hydration Group: Patients receive diuretic therapy and are maintained in a state of negative hydration according to BIA measurements. Positive Hydration Group: Patients are followed without diuretic therapy. All patients are followed for a total duration of 1 year, with clinical evaluations and BIA measurements repeated at 4-month intervals.
Interventions
None listed
Sponsors
Kayseri Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and older (regardless of gender) * Confirmed diagnosis of heart failure (newly diagnosed or previously under follow-up in the internal medicine or cardiology outpatient clinic) * Left ventricular ejection fraction (LVEF) \< 40% as determined by echocardiography * Patients who do not have hypervolemia detected on physical examination * Fluid volume status (overhydration \[OH\]) value greater than zero, as measured by bioimpedance analysis, thereby classifying them as hypervolemic for the study * Willingness to participate and ability to provide written informed consent prior to any study-related procedures
Exclusion criteria
* Patients under 18 years of age * Pregnant women * Patients with clinically evident decompensated heart failure requiring intravenous diuretic therapy * Presence of edema, hepatomegaly, or ascites upon physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fluid Volume Status | Baseline and 12 months | Evaluation of the change in patient's fluid status (hydration/overhydration) measured via bioimpedance analysis (BIA) parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction | Baseline and 12 months | Assessment of cardiac progression by measuring the change in left ventricular ejection fraction percentage using transthoracic echocardiography. |
Countries
Turkey (Türkiye)
Outcome results
None listed