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Acetazolamide Per os for Decompensation of Heart Failure

ConditionChronic Heart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamara State Medical University

About this trial

The main causes of chronic heart failure (CHF) are arterial hypertension and coronary artery disease, less often cardiomyopathy, pericarditis, metastatic myocardial lesions. It should be noted that up to 50% of patients have a preserved left ventricular ejection fraction (LVEF), while its prevalence is progressively increasing annually.

Acute decompensation of CHF is understood as a rapid increase in the severity of clinical manifestations (shortness of breath, severe arterial hypoxemia, the occurrence of arterial hypotension), which caused urgent medical treatment and emergency hospitalization in a patient already suffering from CHF. Decompensation of CHF requires intensification of treatment in order to stabilize the patient's condition. Strengthening diuretic therapy in addition to standard therapy helps to reduce edematous syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women aged 18 years and older

Decompensated CHF NYHA II-IV, which required intravenous administration of diuretics

Any injection fraction of left ventricle*

Signed informed consent to participate in the study.

Disqualifiers

Acetazolamide therapy for a month before hospitalization.

The expected intravenous use of inotropes, vasopressors or sodium nitroprusside at any time of the study.

Exposure to nephrotoxic agents (e.g. contrast dye) is expected within the next 3 days.

Hypersensitivity to acetazolamide, other sulfonamides and / or components of the drug.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetazolamide

    Drug

    Acetazolamide is a diuretic with a mild diuretic effect. Inhibits the enzyme carbonic anhydrase in the proximal convoluted tubule of the nephron. Increases urinary excretion of sodium, potassium, bicarbonate ions, does not affect the excretion of chlorine ions; causes an increase in urine pH.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: a group with the use of acetazolamideExperimental treatment 1 intervention
Group B: a group of standart therapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

decrease of decompensation

achievement of compensation in accordance with the criteria for discontinuation of diuretic therapy.

Time frame
3 days

Secondary outcomes

1

an increase of urine volume

an increase in the volume of urine excreted in the first 72 hours of hospitalization (from the moment of randomization)

Time frame
3 days
2

Weight loss

a decrease of the weight

Time frame
10 days
3

Natriuresis

Natriuresis (evaluation in daily urine)

Time frame
10 days
4

Duration of hospitalization

Duration of hospitalization

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samara State Medical University

Lead sponsor

Source ClinicalTrials.gov
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