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Effects of combined diuretic therapy on exercise capacity, alveolar-capillary diffusion and maintenance of euvolemia in chronic congestive heart failure, diuretic therapy compared with loop diuretics and potassium-sparing diuretics

Phase 3
Recruiting
Conditions
congestive heart failure
Registration Number
2024-519565-21-01
Lead Sponsor
Centro Cardiologico Monzino S.p.A.
Brief Summary

To compare two different treatment strategies (control arm treated with loop diuretic and potassium sparing and experimental arm that will combine such therapy with acetazolamide and free-dose metolazone) in patients with chronic heart failure.

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing, recruiting
Sex
Not specified
Target Recruitment
44
Inclusion Criteria

written informed consent signed

Age: 18-80

Patients with chronic heart failure (at reduced or preserved ejection fraction)

Patients discharged after hospitalization for acute heart failure (at least second episode of decompensation in the past 12 months)

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

age <18 years or >85 years

patients with severe aortic stenosis

patients with severe renal failure (eGFR<20 ml/min/1.73m2 according to CockroftGault)

patients with severe hyponatremia

Medical therapy for heart failure optimized during hospitalization

Documented current pregnancy and lactating status in women of childbearing potential

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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)

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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Centro Cardiologico Monzino S.p.A.

🇮🇹

Milan, Italy

Centro Cardiologico Monzino S.p.A.
🇮🇹Milan, Italy
Pierguseppe Agostoni
Site contact
00390258002586
piergiuseppe.agostoni@cardiologicomonzino.it

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