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

NCT03709160 | Unknown Phase 4

• 1 other identifier: 18-1051
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• MORTALITY

  HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH

  30 DAY

Secondary Outcomes (4)

• REHOSPITALIZATION

  30 DAY

• URINARY FAILURE

  30 DAY

• CLINICAL IMPAIRMENT

  30 DAY

• OEDEMA

  30 DAY

Study Arms (2)

BUMETANIDE

EXPERIMENTAL

we will administrated bumetanide at dosis: oral, 2mg each 8hours for seven day.

Drug: Bumetanide 1 MG

INDAPAMIDE

ACTIVE COMPARATOR

we will administrated indapamide at dosis:oral,1.5MG each 8hours for seven day.

Drug: Bumetanide 1 MG

Interventions

Bumetanide 1 MG DRUG

all patients will be taking the treatment recommended by heart failure guidelines

Also known as: heart failure guidelines treatment

BUMETANIDE; INDAPAMIDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro en Insuficiencia Cardiaca, Mexico: lead

Study Sites (1)

Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia

Mexico City, 14080, Mexico

RECRUITING

Related Publications (1)

• 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.

  PMID: 27206819 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Bumetanide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• EDUARDO CHUQUIURE-VALENZUELA, MD MSc

  HEART FAILURE CENTER INSTITUTO NACIONAL DE CARDIOLOGIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: October 15, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

ME (1)