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

Primary Purpose

Heart Failure, Congestive Heart Failure

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Bumetanide 1 MG

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
-

Sites / Locations

Centro de Insuficiencia Cardiaca Instituto Nacional de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BUMETANIDE

INDAPAMIDE

Arm Description

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

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

Outcomes

Primary Outcome Measures

MORTALITY

HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH

Secondary Outcome Measures

REHOSPITALIZATION

HEART FAILURE REHOSPITALIZATION, CARDIOVASCULAR REHOSPITALIZATION, OTHER REHOSPITALIZATION

URINARY FAILURE

RENAL DETERIORATION (GFR < 50%)

CLINICAL IMPAIRMENT

FUNCTIONAL CLASS DETERIORATION

OEDEMA

ABNORMAL ACCUMULATION OF FLUID (SWOLLEN ANKLE)

Full Information

NCT ID

NCT03709160

First Posted

October 11, 2018

Last Updated

October 15, 2018

Sponsor

Centro en Insuficiencia Cardiaca, Mexico

1. Study Identification

Unique Protocol Identification Number

NCT03709160

Brief Title

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

Acronym

DIVINE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2018 (Anticipated)

Primary Completion Date

October 15, 2019 (Anticipated)

Study Completion Date

October 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro en Insuficiencia Cardiaca, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Congestive Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BUMETANIDE

Arm Type

Experimental

Arm Description

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

Arm Title

INDAPAMIDE

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bumetanide 1 MG

Other Intervention Name(s)

heart failure guidelines treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

MORTALITY

Description

HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH

Time Frame

30 DAY

Secondary Outcome Measure Information:

Title

REHOSPITALIZATION

Description

HEART FAILURE REHOSPITALIZATION, CARDIOVASCULAR REHOSPITALIZATION, OTHER REHOSPITALIZATION

Time Frame

30 DAY

Title

URINARY FAILURE

Description

RENAL DETERIORATION (GFR < 50%)

Time Frame

30 DAY

Title

CLINICAL IMPAIRMENT

Description

FUNCTIONAL CLASS DETERIORATION

Time Frame

30 DAY

Title

OEDEMA

Description

ABNORMAL ACCUMULATION OF FLUID (SWOLLEN ANKLE)

Time Frame

30 DAY

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EDUARDO CHUQUIURE-VALENZUELA, MD MSc

Organizational Affiliation

HEART FAILURE CENTER INSTITUTO NACIONAL DE CARDIOLOGIA

Official's Role

Study Director

Facility Information:

Facility Name

Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CHUQUIURE-VALENZUELA EDUARDO, MD, MSc

Phone

+5215554017407

echuquiurev@yahoo.com

First Name & Middle Initial & Last Name & Degree

EDUARDO CHUQUIURE-VALENZUELA, MD MSc

First Name & Middle Initial & Last Name & Degree

OSCAR FISCAL-LOPEZ, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

27206819

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

Results Reference

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

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