Condition or disease | Intervention/treatment |
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Cardiorenal Syndrome | Device: Ultrafiltration |
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 |
Group/Cohort | Intervention/treatment |
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ULTRAFILTRATION |
Device: Ultrafiltration
Using ultrafiltration to extract the fluid overload from the body of the patients
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DIURETICS |
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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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 |
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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
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |