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

Phase 1

• Conditions: congestive heart failure; MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-003314-37-IT
• Lead Sponsor: CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-10
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)written informed consent signed
2)Age: 18-80
3)Patients with chronic heart failure (at reduced or preserved ejection fraction)
4)Patients discharged after hospitalization for acute heart failure (at least second episode of decompensation in the past 12 months)
5)Patients being treated with loop diuretics at the same or higher dosage of furosemide 40 mg (or equivalent) at the time of admission
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1)age <18 years or >85 years
2)patients with severe aortic stenosis
3)patients with severe renal failure (eGFR<20 ml/min/1.73m2 according to Cockroft-Gault)
4)patients with severe hyponatremia
5)Medical therapy for heart failure optimized during hospitalization
6)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