Clinical trial NCT01210365: Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
Official title: Safety and Efficacy of the Combination of Furosemide 40 mg + Amiloride Hydrochloride 10 mg in the Reduction of Edema of Cardiac Origin in Patients With Congestive Heart Failure Functional Class II (NYHA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: CHF functional class II
Patients with CHF
Patients with CHF functional class II (NYHA) of any etiology
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Centro de Estudos de Diabetes e Hipertensão
state: Ceará
city: Rio de Janeiro
country: Brazil
facility: Hospital dos Servidores do estado - Rio de Janeiro
city: São Paulo
country: Brazil
facility: Casa de Saúde Santa Marcelina
city: São Paulo
country: Brazil
facility: SITCOR Assistência Médica Integrada
Study officials:
affiliation: Casa de Saúde santa Marcelina
name: Juliano N Cardoso
role: PRINCIPAL_INVESTIGATOR
affiliation: SITCOR - Assistência Médica Integrada
name: Rafael S Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital dos Servidores do Estado - Rio de Janeiro
name: Luiz Maurino
role: PRINCIPAL_INVESTIGATOR
References: