Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema

Phase 3

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Drug: Lasix ®; Drug: Diurisa®

• Registration Number: NCT01210365
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief Summary

The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)

Detailed Description

General Purpose

1. To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)

Specific Purposes

1. To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)

2. To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA).

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Study Start: 2011-01-01
• Primary Completion: 2013-03-01
• Study Completion: 2013-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Being over 18 years old
2. Must be able to follow instructions and attend study visits.
3. Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
4. Women of childbearing potential who are using a reliable contraceptive method, as assessed by the principal investigator

Exclusion Criteria

1. Any clinically significant, serious or severe medical condition (e.g., Thyroid, renal or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
2. History of acute myocardial infarction (within 6 months) or decompensated coronary artery disease
3. Pulmonary hypertension - PASP > 45 mmHg
4. Fasting blood glucose above 150 mg/dl
5. Psychiatric or neurological disorders
6. A condition that, according to Principal Investigator's opinion, may interfere with the optimal study participation or which may put the patient at special risk.
7. Participation in any other investigational study within 12 months before signing the ICF.
8. Known medical history of allergy, hypersensitivity or intolerance to any of the components of the drugs to be used in this study.
9. Any medical treatment that is unrelated to the study and scheduled to the clinical trial period, except for non-serious well-controlled comorbidities which are already being followed up medically.
10. Another drug scheduled to be initiated after study entry.
11. Obesity - BMI > 30 kg/m2
12. Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lasix ®	Lasix ®	One group of patients will receive Lasix® (furosemide 40 mg). For treatment, the patient will swallow the tablet in whole form on an empty stomach with some liquid.
furosemide (40 mg) +amiloride (10 mg)	Diurisa®	One group of patients will receive furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow the tablet in whole form on an empty stomach with some liquid.

Primary Outcome Measures

Name	Time	Method
Evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)	5 months	General physical examination and measure of potassium level in blood will be used for measuring the improvement of CHF symptoms and decrease in peripheral edema. The exams will be performed before the enrollment in the clinical study and every 7 days. Patients who have potassium levels below normal (normal K+ ≥ 3.5 mEq/l) after visit 2 may receive oral replacement, at the investigator's discretion, pursuant to the study site routine. The final evaluation will be performed 42 days after the inclusion of the last patient.

Trial Locations

Locations (4)

Centro de Estudos de Diabetes e Hipertensão; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital dos Servidores do estado - Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

Casa de Saúde Santa Marcelina; 🇧🇷 São Paulo, Brazil

SITCOR Assistência Médica Integrada; 🇧🇷 São Paulo, Brazil