NCT01647932

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

Safety and Efficacy of the Combination of Loop Diuretics With Thiazide-type Diuretics in Patients With Decompensated Heart Failure: a Double-blind, Randomized, Placebo-controlled Trial (CLOROTIC Trial).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Spanish Society of Internal Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Volume overload is an important clinical target in heart failure management, typically addressed using loop diuretics. An important and challenging subset of heart failure patients exhibit fluid overload despite significant doses of loop diuretics. One approach to overcome loop diuretic resistance is the addition of a thiazide-type diuretic to produce diuretic synergy via "sequential nephron blockade," first described more than 40 years ago. Although potentially able to induce diuresis in patients otherwise resistant to high doses of loop diuretics, this strategy has not been subjected to large-scale clinical trials to establish safety and clinical efficacy. Combination diuretic therapy using any of several thiazide-type diuretics can more than double daily urine sodium excretion to induce weight loss and edema resolution. To our knowledge there are no clinical trials designed to prove the efficacy and safety of combined diuretic therapy (a commonly used therapy) among patients with decompensated heart failure.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	hydrochlorothiazide	hydrochlorothiazide according to clearance of creatinine; \>50ml/min 25mg daily, 20-50ml/min 50mg daily amd \<20ml/min 100mg daily.
DRUG	Placebo	Placebo according to clearance of creatinine; \>50ml/min 1/2 pill daily, 20-50ml/min 1 pill daily amd \<20ml/min 2 pills daily.

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-12-15
• Completion: 2019-12-15
• First posted: 2012-07-24
• Last updated: 2022-10-04

Locations

1 site across 1 country: Spain