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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Drug: Bumetanide 1 MG

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia
    • Contact: CHUQUIURE-VALENZUELA EDUARDO, MD, MSc; Phone Number: +5215554017407; Email: echuquiurev@yahoo.com
    • Principal Investigator: EDUARDO CHUQUIURE-VALENZUELA, MD MSc
    • Sub-Investigator: OSCAR FISCAL-LOPEZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: heart failure guidelines treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centro en Insuficiencia Cardiaca, Mexico
• Investigators: Study Director: EDUARDO CHUQUIURE-VALENZUELA, MD MSc, HEART FAILURE CENTER INSTITUTO NACIONAL DE CARDIOLOGIA

Publications and helpful links

General Publications

• 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. Erratum In: Eur Heart J. 2016 Dec 30;:

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2018
• Primary Completion (Anticipated): October 15, 2019
• Study Completion (Anticipated): October 15, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Bumetanide
• Other Study ID Numbers: 18-1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individua participant data that underlie results in a publication
• IPD Sharing Time Frame: will be available from the publication up to 10 years after the publication
• IPD Sharing Access Criteria: Upon request addressed to principal investigator, specifying the Statistical Analysis Plan specific points you want to review
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No