Clinical trial • Not applicable • Cardiology

Metolazone for Congestive heart failure

Not applicable trial of Metolazone for Congestive heart failure.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Congestive heart failure
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-01-2025
First CTIS Authorization Date
11-03-2025

Trial design

Control arm: standard therapy with loop diuretic and potassium-sparing diuretic (control arm treated with loop diuretic and potassium sparing; inclusion notes furosemide 40 mg or equivalent). Experimental arm: standard therapy plus acetazolamide (DIAMOX) and metolazone (Zaroxolyn) (combination diuretic therapy); specific doses/schedule not fully specified in the available record. Not applicable trial across 1 site in Italy.

Comparator
Control arm: standard therapy with loop diuretic and potassium-sparing diuretic (control arm treated with loop diuretic and potassium sparing; inclusion notes furosemide 40 mg or equivalent). Experimental arm: standard therapy plus acetazolamide (DIAMOX) and metolazone (Zaroxolyn) (combination diuretic therapy); specific doses/schedule not fully specified in the available record.
Target Sample Size
44

Eligibility

Recruits 44 No vulnerable populations selected; participants must provide written informed consent as per inclusion criterion 'written informed consent signed'..

Pregnancy Exclusion
Documented current pregnancy and lactating status in women of childbearing potential
Vulnerable Population
No vulnerable populations selected; participants must provide written informed consent as per inclusion criterion 'written informed consent signed'.

Inclusion criteria

  • {"criterion_text":"- written informed consent signed\n- Age: 18-80\n- Patients with chronic heart failure (at reduced or preserved ejection fraction)\n- Patients discharged after hospitalization for acute heart failure (at least second episode of decompensation in the past 12 months)\n- Patients being treated with loop diuretics at the same or higher dosage of furosemide 40 mg (or equivalent) at the time of admission"}

Exclusion criteria

  • {"criterion_text":"- age <18 years or >85 years\n- patients with severe aortic stenosis\n- patients with severe renal failure (eGFR<20 ml/min/1.73m2 according to CockroftGault)\n- patients with severe hyponatremia\n- Medical therapy for heart failure optimized during hospitalization\n- Documented current pregnancy and lactating status in women of childbearing potential"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Evaluate differences in the trend of short- to medium-term re-hospitalizations between chronic heart failure patients treated with standard diuretic therapy (control arm) and combination diuretic therapy (experimental arm)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
44
Recruitment Window Months
37
Consent Approach
Participants must provide written informed consent ('written informed consent signed' listed as an inclusion criterion). Subject information and informed consent form documents are included (L1 ICF and privacy notice). Participants are adults (Age: 18-80); no assent procedures for minors are described. Documents/translations in Italian are present.

Geography

Total Number Of Sites
1
Total Number Of Participants
44

Italy

Earliest CTIS Part Ii Submission Date
23-01-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
329
Number Of Sites
1
Number Of Participants
44

Sites

Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Heart Failure and Clinical Cardiology
Principal Investigator Name
Prof. Piergiuseppe Agostoni
Contact Person Name
Pierguseppe Agostoni
Number Of Participants
44

Sponsor

Primary sponsor

Full Name
Centro Cardiologico Monzino S.p.A.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Zaroxolyn 5 mg compresse
Active Substance
Metolazone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation in IT (marketingAuthNumber: 024488 064)
Maximum Dose
5 mg
Investigational Product Name
Zaroxolyn 10 mg compresse
Active Substance
Metolazone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation in IT (marketingAuthNumber: 024488090)
Maximum Dose
5 mg
Investigational Product Name
DIAMOX 250 mg compresse
Active Substance
Acetazolamide
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation in IT (marketingAuthNumber: 009277017)
Maximum Dose
750 mg
Combination Treatment
Yes

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