Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure

• Status: Completed
• Trial end date: 2019-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Society of Internal Medicine
• Treatments: Diuretics; Hydrochlorothiazide; Sodium Potassium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• History of chronic heart failure

• Admission for acute decompensated heart failure

• There is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction

• Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)

Exclusion Criteria:

• Other etiologies of fluid overload different from heart failure

• Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l

• Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission.

• Patients requiring inotropic agents or renal replacement therapies

• Life expectancy < 6 months

• Prior treatment with thiazide-type diuretics

• Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)

• Pregnancy or breastfeeding period

• Active alcoholism and/or other substance abuse