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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2013-03-31

Brief Summary

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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®)

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Detailed Description

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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).

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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furosemide (40 mg) +amiloride (10 mg)

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.

Group Type EXPERIMENTAL

Diurisa®

Intervention Type DRUG

Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks.

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.

Group Type ACTIVE_COMPARATOR

Lasix ®

Intervention Type DRUG

One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.

Interventions

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Diurisa®

Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks.

Intervention Type DRUG

Lasix ®

One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No