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出境医 / 临床实验 / Ultrafiltration Versus Diuretics in Management of Cardiorenal Syndrome

Ultrafiltration Versus Diuretics in Management of Cardiorenal Syndrome

Study Description
Brief Summary:
The aim of the study is to compare the safety and efficacy of ultrafiltration and conventional intravenous diuretic therapy for patients with acute heart failure and cardio-renal syndrome.

Condition or disease Intervention/treatment
Cardiorenal Syndrome Device: Ultrafiltration

Detailed Description:
Heart failure (HF) is a major public health problem with a prevalence of more than 23 million worldwide(Roger VL: Epidemiology of heart failure. Circ Res 2013). Acute decompensated HF (ADHF), defined as 'gradual or rapid change in HF signs and symptoms resulting in a need for urgent therapy', with associated volume overload is the most common cause of hospitalization in heart failure patients. When it is accompanied by worsening in renal function, it is described as a cardio-renal syndrome and is a therapeutic challenge(Acute heart failure syndromes: current state and framework for future research. Circulation 2005). In spite of the major advances in chronic HF management, the morbidity and mortality of ADHF remain high, resulting in the significant impairment of the quality of life of the patients and high health care cost burden. Congestion is the primary reason for hospitalization in a great majority of patients with ADHF. Moreover, adequate decongestion determined by either invasive or noninvasive parameters has been linked with improved outcomes in these patients. Currently available therapeutic regimens for decongestion, which heavily rely on diuretic use, are associated with a number of shortcomings. Diuretics are known to cause electrolyte abnormalities, deterioration of renal function, neuro hormonal activation, and non-renal adverse effects. Suboptimal diuresis, diuretic resistance, and unpredictability of the therapeutic response pose additional challenges for the use of these medications in the setting of ADHF, which in turn lead to worsening or lingering congestion(Gheorghiade M, Filippatos G: Reassessing treatment of acute heart failure syndromes: the ADHERE Registry. Eur Heart J Suppl 2005). Unfortunately, the newer pharmacologic agents such as endothelin receptor antagonists, vasopressin receptor antagonists, and adenosine-A1 receptor antagonists have failed to prove their role as safe and effective alternatives to conventional therapies. Consequently, there has been a renewed interest in exploring non-pharmacologic therapies like mechanical extraction of the excess fluid (i.e. ultrafiltration (UF)) as an effective alternative to the conventional approaches aimed at decongestion in ADHF. Ultrafiltration is a mechanical fluid removal procedure designed to treat patients who have an excess of fluid in their bodies and have difficulty removing fluid with diuretics. The goal of treatment is to restore fluid balance in the body. UF therapy has several proposed advantages including relatively rapid, predictable, and adjustable fluid removal, activation of the renin-angiotensin-aldosterone system to a lower degree compared with diuretics, and more effective sodium removal.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrafiltration Versus Diuretics in Management of Cardiorenal Syndrome
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
ULTRAFILTRATION Device: Ultrafiltration
Using ultrafiltration to extract the fluid overload from the body of the patients

DIURETICS
Outcome Measures
Primary Outcome Measures :
  1. death and/or unscheduled hospitalization [ Time Frame: up to 12 months post-randomization ]
    The primary outcome measure is a combined measure including death whatever the cause, and/or unscheduled hospitalization for acute decompensated heart failure. For each groups, deaths, cause and time of deaths will be recorded. Hospitalization date, duration, location, and reason will be recorded. The "hospitalization" setting and the "acute decompensated heart failure" setting will be endorsed by an event validation committee.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 12 months ]
    number of days spent alive and not hospitalized and Intervention effect on one-year overall survival

  2. Hospitalization for acute decompensated heart failure [ Time Frame: up to 12 months post- randomization ]

    Intervention effect on :

    Period before first unscheduled hospitalization for acute decompensated heart failure Number and duration of hospitalizations for acute heart failure (scheduled or not) throughout the year Number and duration of unscheduled hospitalization for acute heart failure throughout the year.



Eligibility Criteria
Layout table for eligibility information
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
The patient population consisted of 100 individuals who were admitted to hospital with acute decompensated heart failure, and who developed cardiorenal syndrome as defined as an increase in serum creatinine of >0.3 mg/dL from baseline.
Criteria

Inclusion Criteria:

  • Patients who were admitted to hospital with acute decompensated heart failure, and who developed cardiorenal syndrome as defined as an increase in serum creatinine of >0.3 mg/dL from baseline. Patients were required to have at least 2 of the following characteristics: peripheral edema, jugular venous pressure >10 cm water, or pulmonary edema or effusion as assessed by radiography.

Exclusion Criteria:

  • Patients with creatinine >3.5 mg/dL, likely excluding any individuals with severe CKD. Other exclusion criteria included those who were hemodynamically unstable, requiring intravenous vasodilators or inotropic agents.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 18, 2019
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
death and/or unscheduled hospitalization [ Time Frame: up to 12 months post-randomization ]
The primary outcome measure is a combined measure including death whatever the cause, and/or unscheduled hospitalization for acute decompensated heart failure. For each groups, deaths, cause and time of deaths will be recorded. Hospitalization date, duration, location, and reason will be recorded. The "hospitalization" setting and the "acute decompensated heart failure" setting will be endorsed by an event validation committee.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Survival [ Time Frame: 12 months ]
    number of days spent alive and not hospitalized and Intervention effect on one-year overall survival
  • Hospitalization for acute decompensated heart failure [ Time Frame: up to 12 months post- randomization ]
    Intervention effect on : Period before first unscheduled hospitalization for acute decompensated heart failure Number and duration of hospitalizations for acute heart failure (scheduled or not) throughout the year Number and duration of unscheduled hospitalization for acute heart failure throughout the year.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrafiltration Versus Diuretics in Management of Cardiorenal Syndrome
Official Title Ultrafiltration Versus Diuretics in Management of Cardiorenal Syndrome
Brief Summary The aim of the study is to compare the safety and efficacy of ultrafiltration and conventional intravenous diuretic therapy for patients with acute heart failure and cardio-renal syndrome.
Detailed Description Heart failure (HF) is a major public health problem with a prevalence of more than 23 million worldwide(Roger VL: Epidemiology of heart failure. Circ Res 2013). Acute decompensated HF (ADHF), defined as 'gradual or rapid change in HF signs and symptoms resulting in a need for urgent therapy', with associated volume overload is the most common cause of hospitalization in heart failure patients. When it is accompanied by worsening in renal function, it is described as a cardio-renal syndrome and is a therapeutic challenge(Acute heart failure syndromes: current state and framework for future research. Circulation 2005). In spite of the major advances in chronic HF management, the morbidity and mortality of ADHF remain high, resulting in the significant impairment of the quality of life of the patients and high health care cost burden. Congestion is the primary reason for hospitalization in a great majority of patients with ADHF. Moreover, adequate decongestion determined by either invasive or noninvasive parameters has been linked with improved outcomes in these patients. Currently available therapeutic regimens for decongestion, which heavily rely on diuretic use, are associated with a number of shortcomings. Diuretics are known to cause electrolyte abnormalities, deterioration of renal function, neuro hormonal activation, and non-renal adverse effects. Suboptimal diuresis, diuretic resistance, and unpredictability of the therapeutic response pose additional challenges for the use of these medications in the setting of ADHF, which in turn lead to worsening or lingering congestion(Gheorghiade M, Filippatos G: Reassessing treatment of acute heart failure syndromes: the ADHERE Registry. Eur Heart J Suppl 2005). Unfortunately, the newer pharmacologic agents such as endothelin receptor antagonists, vasopressin receptor antagonists, and adenosine-A1 receptor antagonists have failed to prove their role as safe and effective alternatives to conventional therapies. Consequently, there has been a renewed interest in exploring non-pharmacologic therapies like mechanical extraction of the excess fluid (i.e. ultrafiltration (UF)) as an effective alternative to the conventional approaches aimed at decongestion in ADHF. Ultrafiltration is a mechanical fluid removal procedure designed to treat patients who have an excess of fluid in their bodies and have difficulty removing fluid with diuretics. The goal of treatment is to restore fluid balance in the body. UF therapy has several proposed advantages including relatively rapid, predictable, and adjustable fluid removal, activation of the renin-angiotensin-aldosterone system to a lower degree compared with diuretics, and more effective sodium removal.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patient population consisted of 100 individuals who were admitted to hospital with acute decompensated heart failure, and who developed cardiorenal syndrome as defined as an increase in serum creatinine of >0.3 mg/dL from baseline.
Condition Cardiorenal Syndrome
Intervention Device: Ultrafiltration
Using ultrafiltration to extract the fluid overload from the body of the patients
Study Groups/Cohorts
  • ULTRAFILTRATION
    Intervention: Device: Ultrafiltration
  • DIURETICS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 16, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who were admitted to hospital with acute decompensated heart failure, and who developed cardiorenal syndrome as defined as an increase in serum creatinine of >0.3 mg/dL from baseline. Patients were required to have at least 2 of the following characteristics: peripheral edema, jugular venous pressure >10 cm water, or pulmonary edema or effusion as assessed by radiography.

Exclusion Criteria:

  • Patients with creatinine >3.5 mg/dL, likely excluding any individuals with severe CKD. Other exclusion criteria included those who were hemodynamically unstable, requiring intravenous vasodilators or inotropic agents.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024306
Other Study ID Numbers Ultrafiltration in CRS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Muhammad Abderazek Ahmad, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2019