Efficacy of Oral Acetazolamide in Decongestion in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Efficacy of Oral Acetazolamide as Add-on Diuretic Therapy in Decongestion in Patients With Heart Failure and Diuretic Resistance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05940220
• Other study ID #: IR.TUMS.THC.REC.1402.016
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 30, 2023
• Est. completion date: October 10, 2025

Study information

• Verified date: June 2023
• Source: Tehran University of Medical Sciences
• Contact: ALI Bozorgi, Associate Professor
• Phone: (+9821) 88029758
• Email: alibozorgi2001[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a 1:1 ratio single center, double-blind, RCT on the diuretic and decongestive effects of oral acetazolamide in Iranian patients with HF. This study will be conducted on heart failure patients whose symptoms of congestion are not relieved by oral diuretics and are temporarily hospitalized in a section called the infusion ward and receive intravenous diuretics. The infusion unit is a separate unit where patients with heart failure who are not adequately relieved by oral diuretics are admitted for a short period of time and receive injectable furosemide. In this study, 250 mg acetazolamide tablets and placebo and furosemide 20 mg will be used. The medical information of the patients will be recorded, patients' clinical status will be evaluated by calculating the EVEREST score at baseline and third day , the weight and laboratory indices will also be measured at baseline and third day based on the same scale and fixed laboratory kits, respectively. Blood pressure will be also measured by an expert nurse at the baseline and each day before the furosemide injection by the same blood pressure cuff. Patients will be followed for clinical events to day 90. The protocol was drafted according to the standard protocol items for clinical trials) SPIRIT) guideline for randomized clinical trial protocols. Study objectives The main objective is to determine the effect of oral acetazolamide and furosemide, as a loop diuretic, combination therapy on improvement of the congestion in patients at baseline and third day. Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days. Prespecified secondary objectives included the following: N-terminal pro B-type natriuretic peptide (NT-proBNP) level on the 30th day, the hospitalization rate in a three-month period, comparison of quality of life between two groups at the end of the third month and change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count (CBC) at third day of the trial. At the end of the third month, we will assess our patients' quality of life using the Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire. The validity and reliability of this questionnaire, which has 16 questions in 5 dimentions, has been confirmed by Naderi et al in 2012. (Kornbach's alpha coefficient= 0.922) .This questionnaire offers a range of total scores between 20 and 66. The items are scored on a three- or four-point Likert scale, with a higher score indicating a better quality of life for the individual. These are the five dimensions that are the subject of this survey: severity of disease symptoms (items 1, 2, 3, 4, 6), physical limitations (items 7-1 to 7-6), mental limitations (items 5, 9, 11), social aspects (items 8, 10, 12, 13), self-care (items 14, 15) and the patient's overall satisfaction (item 16). (16)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: October 10, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Earn at least 8 points from EVEREST score (see Table 1.)

2. Adult patients (= 18 years)

3. 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.

4. Maintenance treatment with oral furosemide as a loop diuretic =20 mg for at least one month

5. Using SGLT2i drugs including canagliflozin, dapagliflozin, and empagliflozin for at least one month Exclusion criteria

1. Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg

2. Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m2

3. Using any diuretic agent except mineralocorticoid receptor antagonists including spironolactone and eplerenone

4. 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Acetazolamide
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
• placebo
placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Houshang bavandpour karvane	Tehran	Tehran Heart Center

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	N-terminal pro B-type natriuretic peptide (NT-proBNP) level	N-terminal pro B-type natriuretic peptide (NT-proBNP) level	30th day
Secondary	Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire	This questionnaire offers a range of total scores between 20 and 66	3 months