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Heart FailurePhase 4DIVINENCT03709160

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

A Phase 4 study testing Bumetanide 1 MG in people with Heart Failure and Congestive Heart Failure, run by Centro en Insuficiencia Cardiaca, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive Heart Failure
What is being tested?
Bumetanide 1 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMexico
Study dates
15 Oct 2018to 15 Oct 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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
  • -

Trial locations and contacts

1 site in 1 country.

Mexico1 site, 1 recruiting

  • Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia

    Mexico City, 14080

    CHUQUIURE-VALENZUELA EDUARDO, MD, MSc, +5215554017407, echuquiurev@yahoo.com

    EDUARDO CHUQUIURE-VALENZUELA, MD MSc

    Recruiting

Other trials in Mexico

About this study

Official title: 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.

Read the 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).

Being tested
Bumetanide 1 MG
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bumetanide 1 MGDrug

    Also called heart failure guidelines treatment

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

Study groups in NCT03709160
Study groupRoleWhat they receive
BUMETANIDEExperimentalwe will administrated bumetanide at dosis: oral, 2mg each 8hours for seven day.
Receives: Drug: Bumetanide 1 MG
INDAPAMIDEActive comparatorwe will administrated indapamide at dosis:oral,1.5MG each 8hours for seven day.
Receives: Drug: Bumetanide 1 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MORTALITY

    HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH

    Measured: 30 DAY

Secondary outcomes (4)

  1. REHOSPITALIZATION

    HEART FAILURE REHOSPITALIZATION, CARDIOVASCULAR REHOSPITALIZATION, OTHER REHOSPITALIZATION

    Measured: 30 DAY

  2. URINARY FAILURE

    RENAL DETERIORATION (GFR < 50%)

    Measured: 30 DAY

  3. CLINICAL IMPAIRMENT

    FUNCTIONAL CLASS DETERIORATION

    Measured: 30 DAY

  4. OEDEMA

    ABNORMAL ACCUMULATION OF FLUID (SWOLLEN ANKLE)

    Measured: 30 DAY

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start15 Oct 2018 (estimated)
  3. Primary completion15 Oct 2019 (estimated)
  4. Study completion15 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709160
Sponsor's protocol ID
18-1051
Acronym
DIVINE
Status last verified
Oct 2018
First submitted
11 Oct 2018
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individua participant data that underlie results in a publication

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.

    PubMed 27206819

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bumetanide 1 MG in people with Heart Failure and Congestive Heart Failure, run by Centro en Insuficiencia Cardiaca, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MORTALITY (time frame: 30 DAY). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03709160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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