Efficacy of Oral Acetazolamide in Decongestion in Patients With Heart Failure

NCT05940220 | Unknown Phase 3

• 1 other identifier: IR.TUMS.THC.REC.1402.016
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 1:1 ratio single-center, double-blind, randomized controlled trial, aiming to enroll 130 patients admitted in infusion ward. The participants receive furosemide as standard treatment and will randomize towards 250 mg oral acetazolamide twice a day versus placebo on three consecutive days. The main objective is to determine the effect of oral acetazolamide and furosemide combination therapy on the decongestion. Prespecified secondary objectives included N-terminal pro B-type natriuretic peptide level on the 30th day, the readmission rate in a three-month period, quality of life assessment by Heart Failure Quality of Life Questionnaire at the end of the third month, change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count at third day of the trial.

Conditions

Heart Failure

Keywords

: Acetazolamide, Heart failure, Electrolyte Disturbance, Diuretics, Chloride, Diuretic resistance, Decongestion

Outcome Measures

Primary Outcomes (1)

• Na/cr Ratio

  . Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days.

  baseline and third day

Secondary Outcomes (2)

• N-terminal pro B-type natriuretic peptide (NT-proBNP) level

  30th day

• Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire

  3 months

Study Arms (2)

acetazolamid

ACTIVE COMPARATOR

We will administer injectable and oral furosemide in infusion ward based on the dosage determined by the specialist on day zero. After that, we continue oral furosemide administration for three days. The prescribed dose of injectable and oral furosemide is determined by the specialist based on previous visits and hospitalizations in such a way that the patient has the least symptoms. The intervention group will receive acetazolamide 500 mg on day zero, then 250 mg bd for two days and 250 mg on the third day. The control group will receive placebo equivalent to acetazolamide.

Other: Acetazolamide

placebo

PLACEBO COMPARATOR

Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm.

Other: placebo

Interventions

Acetazolamide OTHER

Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm

acetazolamid

placebo OTHER

placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Earn at least 8 points from EVEREST score (see Table 1.)
• Adult patients (≥ 18 years)
• A major clinical sign of volume overload including edema, ascites confirmed by abdominal ultrasound, or pleural effusion confirmed by chest x-ray or chest ultrasound without using iv furosemide.
• Maintenance treatment with oral furosemide as a loop diuretic ≥20 mg for at least one month
• Using SGLT2i drugs including canagliflozin, dapagliflozin, and empagliflozin for at least one month

You may not qualify if:

• Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg
• Estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73 m2
• Using any diuretic agent except mineralocorticoid receptor antagonists including spironolactone and eplerenone
• Simultaneous diagnosis of acute coronary syndrome, which is characterized by typical chest pain in addition to an increase in troponin level above the 99th percentile or electrocardiographic changes indicating ischemia or hospitalization as unstable angina.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Houshang bavandpour karvane

Tehran, Tehran Heart Center, 1416753955, Iran

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

ALI Bozorgi, Associate Professor

CONTACT

(+9821) 88029758; alibozorgi2001@yahoo.com

Houshang bavandpour karvane, resident of cardiology

CONTACT

Houshang.bavandpour20@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: December 30, 2023
• Primary Completion: June 30, 2025
• Study Completion: October 10, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-06

Locations

IR (1)