NCT05631275|Unknown
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Sponsor study identifier
observational
100
1 country
1
Study Start
September 7, 2022
Actual (reported)Primary Completion
December 7, 2022
Actual (reported)Study Completion
September 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heart failure (HF) represents a major problem in today's health care landscape and is expected to grow in the next years due to an aging population and improved treatments. In many cases, the evaluation of the volemia status of patients with left ventricular dysfunction is not easy in the outpatient setting, due to limitations of physical examination in stable patients, as well as the tolerance to chronic HF they have. The aim of this study is to determine whether the bioelectrical impedance analysis (BIA) is useful in determining the real clinical stability of chronic HF, its potential implications for clinical management and patient follow-up, as well as for the adjustment of pharmacological treatment. This study is observational, single-center, single-blind and outpatient. It includes patients with a previous diagnosis of HF and left ventricular ejection fraction (LVEF) ≤ 40%, who are stable at the time of inclusion. Follow-up is estimated to be 12 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2022
Actual (reported)November 21, 2022
Actual (reported)November 30, 2022
Actual (reported)December 7, 2022
Actual (reported)September 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patients Volemia status
determine the volemia status of the patients with the BIA parameters
15 minutes
The study population is outpatients attended at cardiology consultations of the Hospital Universitario Fundación Jiménez Díaz, with a diagnosis of stable HF (without admission due to decompensation or first episode of HF in the previous year) and with a LVEF ≤ 40%
Fundación Jiménez Dia University Hospital, IIS-FJD
Madrid, 28040, Spain
Hans Gaebelt, MD, PhD
Fundación Jiménez Dia University Hospital, IIS-FJD
First Submitted
November 21, 2022
First Posted
November 30, 2022
Study Start
September 7, 2022
Actual (reported)Primary Completion
December 7, 2022
Actual (reported)OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
Contact the study team to confirm eligibility.
Study Completion
September 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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