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NCT Number: NCT07801144

Bioimpedance-Guided Diuretics and Cardiac Progression in Asymptomatic Heart Failure

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Fluid Volume Status

    Time frame: Baseline and 12 months

    Evaluation of the change in patient's fluid status (hydration/overhydration) measured via bioimpedance analysis (BIA) parameters.

Secondary outcomes

  1. Change in Left Ventricular Ejection Fraction

    Time frame: Baseline and 12 months

    Assessment of cardiac progression by measuring the change in left ventricular ejection fraction percentage using transthoracic echocardiography.

Sponsors and collaborators

Lead sponsor

Kayseri Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Diuretic Treatment Based on Bioimpedance Analysis Measurements on Cardiac Progression in Patients With Asymptomatic Heart Failure: 1-Year Period, Longitudinal Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

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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