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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure. DIVINE STUDY

Conditions
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Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Drug: Bumetanide 1 MG


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUMETANIDE<br>we will administrated bumetanide at dosis: oral, 2mg each 8hours for seven day. | Drug: Bumetanide 1 MG<br>* all patients will be taking the treatment recommended by heart failure guidelines<br>* Other names: heart failure guidelines treatment;|
| Active Comparator: INDAPAMIDE<br>we will administrated indapamide at dosis:oral,1.5MG each 8hours for seven day. | Drug: Bumetanide 1 MG<br>* all patients will be taking the treatment recommended by heart failure guidelines<br>* Other names: heart failure guidelines treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MORTALITY | HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH | 30 DAY | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REHOSPITALIZATION | HEART FAILURE REHOSPITALIZATION, CARDIOVASCULAR REHOSPITALIZATION, OTHER REHOSPITALIZATION | 30 DAY | 
| URINARY FAILURE | RENAL DETERIORATION (GFR < 50%) | 30 DAY | 
| CLINICAL IMPAIRMENT | FUNCTIONAL CLASS DETERIORATION | 30 DAY | 
| OEDEMA | ABNORMAL ACCUMULATION OF FLUID (SWOLLEN ANKLE) | 30 DAY |