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Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure (DIVINE)

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ClinicalTrials.gov Identifier: NCT03709160
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Centro en Insuficiencia Cardiaca, Mexico

Brief Summary:
In the present study, consecutive patients, older than 18 years, of both genders will be included. The diagnosis of reduced Heart Failure (HfrEF) according to: Clinical pattern, laboratories and Cardiac imaging (ESC criteria). Treatment will be assigned in two groups: Bumetanide and another group will be received Indapamide. Each group received maximum tolerated dose for seven days with Clinical and labs evaluations will be every 48 hrs. (Face-to-face and/or telephone visits). Serum and urinary labs, EKG´s, Echo will be evaluated. Daily in-home register will made. Final points were: Mortality, Urinary failure, Clinical Impairment, Hospital admissions, Oedema. (MUCHO). All patients will be followed for 30 days.

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Drug: Bumetanide 1 MG Phase 4

Detailed Description:
In selected patients who sign informed consent with decompensation of cardiac failure by water congestion will be allocated in two groups: Bumetanide and the other Indapamide group. Each group will be given the maximum tolerated dose for seven days with clinical evaluations every 48 hours. (Face to face and/or telephone). Clinical variables, ECG and serum and urine laboratories will be assessed finally, patients will follow up for 30 days. To identify endpoints such as: mortality, urinary failure, clinical deterioration, hospital admissions, edema. (MUCHO).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure. DIVINE STUDY
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: BUMETANIDE
we will administrated bumetanide at dosis: oral, 2mg each 8hours for seven day.
Drug: Bumetanide 1 MG
all patients will be taking the treatment recommended by heart failure guidelines
Other Name: heart failure guidelines treatment

Active Comparator: INDAPAMIDE
we will administrated indapamide at dosis:oral,1.5MG each 8hours for seven day.
Drug: Bumetanide 1 MG
all patients will be taking the treatment recommended by heart failure guidelines
Other Name: heart failure guidelines treatment




Primary Outcome Measures :
  1. MORTALITY [ Time Frame: 30 DAY ]
    HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH


Secondary Outcome Measures :
  1. REHOSPITALIZATION [ Time Frame: 30 DAY ]
    HEART FAILURE REHOSPITALIZATION, CARDIOVASCULAR REHOSPITALIZATION, OTHER REHOSPITALIZATION

  2. URINARY FAILURE [ Time Frame: 30 DAY ]
    RENAL DETERIORATION (GFR < 50%)

  3. CLINICAL IMPAIRMENT [ Time Frame: 30 DAY ]
    FUNCTIONAL CLASS DETERIORATION

  4. OEDEMA [ Time Frame: 30 DAY ]
    ABNORMAL ACCUMULATION OF FLUID (SWOLLEN ANKLE)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Older over 18 year 2. Both gender. 3. Patients are able to read, write and understand. 4.-Heart failure criteria:a) Clinical signs and symptoms b) serum NTP-proBNP: over 125pg/ml. or serum bnp: over: 35pg/ml. c) Left ventricular ejection fraction under 40% ( By any image study: echocardiogram, Tomography , MRI,Nuclear medicine.) 5. Commitment to participate in the follow-up of the present study.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with deterioration of their clinical condition that warrant rapid attention by the emergency department.
  3. Patients with symptomatic hypotension by arterial pressure over; 90/50 mmHg.
  4. Symptomatic heart rate disorders: tachycardia greater than 120 beats per minute or bradycardia less than 50 beats per minute.
  5. Patients with respiratory impairment: by tachypnea (respiratory rate greater than 22 per min), peripheral oxygen saturation less than 90%.
  6. Clinical signs or by methods of pleural effusion image that compromise the ventilatory mechanism.
  7. Hormonal thyroid decontrol (thyroid hormone profile outside the reference range)
  8. Serum glucose numbers greater than 140mg/DL and/or glycosylated hemoglobin greater than 6.5%.
  9. Renal damage characterized by serum creatinine numbers greater than 1.5 mg/DL.
  10. Alteration of the hepatic test: serum aspartate aminotransferase and/or serum alanine aminotransferase by levels greater than three times the upper limit of reference.
  11. Alterations in serum electrolytes (by sodium greater 135 mmol/L or less 145 mmol; Potassium less than 3.5 mmol/L or higher 5.35 mmol/L)
  12. Intolerance or allergy recognized for any diuretic.
  13. Comorbidities that prevent the follow-up of treatment: (Alcoholism, drug addiction, psychiatric disorders)
  14. Positive serology carriers for Hepatitis (B, C) HIV.
  15. Acute myocardial infarction (with and without elevation) in the last three months.
  16. History of vascular (ischemic or hemorrhagic) brain disease in the last three months.
  17. Carriers of acute inflammatory and/or immunologic disease in the last three months (e.g. Active Lupus etc.)
  18. Active myocarditis in the last three months
  19. History of Prostatism, or recognized prostatic alterations, that impede voiding flow.
  20. Terminal cancer
  21. Blunt physical and cognitive deterioration that prevents optimal follow-up.
  22. Cultural barriers involving limitation of communication (languages, dialects, reading and writing, etc.).
  23. Not to sign informed consent

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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): NCT03709160


Locations
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Mexico
Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia Recruiting
Mexico City, Mexico, 14080
Contact: CHUQUIURE-VALENZUELA EDUARDO, MD, MSc    +5215554017407    echuquiurev@yahoo.com   
Principal Investigator: EDUARDO CHUQUIURE-VALENZUELA, MD MSc         
Sub-Investigator: OSCAR FISCAL-LOPEZ, MD         
Sponsors and Collaborators
Centro en Insuficiencia Cardiaca, Mexico
Investigators
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Study Director: EDUARDO CHUQUIURE-VALENZUELA, MD MSc HEART FAILURE CENTER INSTITUTO NACIONAL DE CARDIOLOGIA

Publications:
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Responsible Party: EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Principal Investigator, Centro en Insuficiencia Cardiaca, Mexico
ClinicalTrials.gov Identifier: NCT03709160     History of Changes
Other Study ID Numbers: 18-1051
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individua participant data that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: will be available from the publication up to 10 years after the publication
Access Criteria: Upon request addressed to principal investigator, specifying the Statistical Analysis Plan specific points you want to review

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Indapamide
Bumetanide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors