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Trial record 2 of 4 for:    21366472 [PUBMED-IDS]

Loop Diuretic Therapy in Acutely Decompensated Heart Failure (DIUR-AHF)

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ClinicalTrials.gov Identifier: NCT02638142
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : June 6, 2017
Sponsor:
Collaborators:
Azienda Ospedaliera di Padova
Ospedale Madonna della Navicella
University of Roma La Sapienza
Information provided by (Responsible Party):
Alberto Palazzuoli MD PhD, University of Siena

Brief Summary:
DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.

Condition or disease Intervention/treatment
Acute Heart Failure Drug: Continuous Furosemide Infusion Drug: Intermittent Furosemide Infusion

Detailed Description:

The use of intravenous loop diuretics is a cornerstone of therapy for acutely decompensated heart failure (ADHF); significant concerns have been raised regarding risks and benefits of loop diuretics, particularly about dosage and administration regimen.

Recent guidelines recommend the use of these drugs to reduce left ventricular filling pressure, avoid pulmonary edema, and alleviate peripheral fluid retention.

Some studies have provided guidelines for the administration of these drugs in clinical practice, but data interpretation remains challenging due to the frequent exclusion of patients with kidney disease from major ADHF clinical trials. Therefore, it is not clear if continuous infusion is better than intermittent boluses in terms of decongestion, maintenance of renal filtration function and prognosis.

On the other hand, continuous administration should provide a more constant delivery of the drug into the tubule, potentially reducing these phenomena.

The aim of the study is to evaluate the better loop diuretic intravenous administration in terms of renal function, congestion signs, BNP and outcome.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Continuous Versus Bolus Intermittent Loop Diuretic Infusion in Acutely Decompensated Heart Failure: Evaluation of Renal Function, Congestion Signs, BNP and Outcome
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Group/Cohort Intervention/treatment
Continuous Furosemide Infusion
continuous intravenous furosemide infusion
Drug: Continuous Furosemide Infusion
Intravenous continuous Furosemide infusion
Other Name: cIV

Intermittent Furosemide Infusion
bolus intermittent intravenous furosemide infusion
Drug: Intermittent Furosemide Infusion
Intravenous bolus intermittent Furosemide Infusion
Other Name: iIV




Primary Outcome Measures :
  1. Cardiac death and rehospitalization for HF [ Time Frame: 180 days ]
    Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.


Secondary Outcome Measures :
  1. length of hospital stay (days) [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    evaluation of length of hospital stay (days) in the two groups

  2. Inotropes agents [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    Need to use inotropes agents during the treatment

  3. hypertonic saline solution [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    need to use hypertonic saline solution during the treatment

  4. Acute kidney injury [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration

  5. Body weight changes [ Time Frame: from admission to discharge (7-12 days) ]
    Body weight changes in two groups from the admission to discharge

  6. Diuresis [ Time Frame: from admission to discharge (7-12 days) ]
    mean urine output in two groups from the admission to discharge

  7. BNP changes [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    mean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization.

  8. BUN changes [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization.

  9. Reduction of edema [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    Evaluation of edema regression (or not) after treatment in the two groups.

  10. Reduction of dyspnea [ Time Frame: From date of randomization until the discharge (7-12 days) ]
    Evaluation of dyspnea scale reduction (or not) after treatment in the two groups.

  11. Regression of pulmonary congestion [ Time Frame: From date of randomization ]
    Evaluation of pulmonary congestion regression (or not) after treatment in the two groups, considering Chest X-ray at admission and at discharge

  12. Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) [ Time Frame: From hospital admission until the discharge (7-12 days) ]
    Evaluation of persistence of congestion (or not) and incidence of AKI (or not) according to quartiles of diuretic efficiency.

  13. High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage [ Time Frame: 180 days ]
    Number of patients with high in-hospital diuretic dosage who were affected by adverse outcome.

  14. Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) [ Time Frame: 180 days ]
    Number of patients (according quartiles of diuretic efficiency) who were affected by adverse outcome.


Biospecimen Retention:   Samples Without DNA
blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who met diagnostic criteria for ADHF, independently from systolic function by exhibiting: at least one symptom at rest between dyspnea, orthopnea, peripheral edema and major fatigue; and at least two clinical signs including rales, pulmonary congestion on chest radiography, jugular vein dilatation and a third heart sound. An elevation in blood BNP >100 pg/ml was considered supportive for a diagnosis of ADHF
Criteria

Inclusion Criteria:

  • Patients over 18 years;
  • Patients with diagnosis of ADHF(dyspnea, orthopnea, peripheral edema or major fatigue and at least two clinical signs including rales, hepatomegaly, pulmonary congestion on chest radiography, jugular vein dilatation, or a third heart sound);
  • Blood BNP > 100 pg/mL;

ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.

Exclusion Criteria:

  • Patients who receive more than 40 mg of IV furosemide;
  • End-Stage renal disease or renal replacement therapy;
  • Recent myocardial infarction (within thirty days of screening);
  • Systolic blood pressure < 80 mmHg;
  • Creatinine levels > 4 mg/dL;
  • Patients affected by sepsis, liver diseases, inflammatory diseases or neoplastic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638142


Contacts
Contact: Alberto Palazzuoli, MD +390577585363 palazzuoli2@unisi.it
Contact: Gaetano Ruocco, MD +393386577898 gmruocco@virgilio.it

Locations
Italy
Ospedale Madonna della Navicella Recruiting
Chioggia, Venezia, Italy
Contact: Roberto Valle, MD         
Principal Investigator: Roberto Valle, MD         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy
Contact: Giorgio Vescovo, MD         
Principal Investigator: Giorgio Vescovo, MD         
University of Rome La Sapienza Recruiting
Roma, Italy, 00189
Contact: Salvatore Di Somma, MD    +3906.33775581    salvatore.disomma@uniroma1.it   
Principal Investigator: Salvatore Di Somma, MD         
Department of Internal Medicine, Cardiovascular Diseases Unit Recruiting
Siena,, Italy, 53100
Contact: Alberto Palazzuoli, MD    +39577585363    palazzuoli2@unisi.it   
Principal Investigator: Alberto Palazzuoli, MD         
Sub-Investigator: Gaetano Ruocco, MD         
Sponsors and Collaborators
University of Siena
Azienda Ospedaliera di Padova
Ospedale Madonna della Navicella
University of Roma La Sapienza
Investigators
Principal Investigator: Alberto Palazzuoli, MD University of Siena

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberto Palazzuoli MD PhD, Medical Doctor, Cardiologist, University of Siena
ClinicalTrials.gov Identifier: NCT02638142     History of Changes
Other Study ID Numbers: DIUR-AHF
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alberto Palazzuoli MD PhD, University of Siena:
loop diuretic
heart failure
renal dysfunction
congestion signs
BNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action