Clinical trial NCT03709160: Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure
Official title: Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure. DIVINE STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Congestive Heart Failure
Lead sponsor: Centro en Insuficiencia Cardiaca, Mexico
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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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Primary outcomes:
measure: MORTALITY
timeFrame: 30 DAY
Secondary outcomes:
measure: REHOSPITALIZATION
timeFrame: 30 DAY
measure: URINARY FAILURE
timeFrame: 30 DAY
measure: CLINICAL IMPAIRMENT
timeFrame: 30 DAY
measure: OEDEMA
timeFrame: 30 DAY
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia
Study officials:
affiliation: HEART FAILURE CENTER INSTITUTO NACIONAL DE CARDIOLOGIA
name: EDUARDO CHUQUIURE-VALENZUELA, MD MSc
role: STUDY_DIRECTOR
References:
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.