None listed
Conditions
Interventions
One losartan 50 mg tablet and one placebo tablet corresponding to losartan 100 mg during the study. The treatment with losartan will be administered once a day in the morning for a week
Group name:Arm 2 Type of group
One tablet of losartan 50 mg plus one placebo tablet corresponding to losartan 100 mg for one week, then the dose of losartan was increased to 100 mg and they received one placebo tablet corresponding to losartan 50 mg and one losartan tablet of 100 mg. Subsequently, patients were increased the dose of losartan to 150 mg and received one losartan 50 mg tablet and one losartan 100 mg tablet for one week
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Be at least 18 years old. • Have symptomatic heart failure (NYHA Functional Class II, m or IV) with known or newly diagnosed intolerance to treatment with ACE inhibitors and who is currently receiving or not an Angiotensin II Antagonist (AAII). The intolerance to the lECA according to the clinical criteria of the investigator is defined as the therapy with a lECA discontinued by an event related to an ACEI that includes: cough, symptomatic hypotension, azotemia, hyperkalemia, dysgeusia, rash or gastrointestinal disorder In patients with intolerance to the ACE inhibitors recently diagnosed, these symptoms must have decreased after 2 weeks of discontinuation of treatment with an ACE inhibitor. • Have a left ventricular ejection fraction <40% as measured by a validated method (eg, radionuclide ventriculography, contrast angiography, MRI, or echocardiography within 3 months prior to randomization). If the patient has had an intercurrent event, the measurement of the ejection fraction should be confirmed before randomization. • Have received unchanged doses of concomitant cardiovascular therapy (including diuretics, digitalis, vasodilators, alpha and beta adrenergic receptor antagonists, and calcium channel blockers, AAUs, etc.) for at least 14 days before the transition period of open tag.
Exclusion criteria
Exclusion criteria: • Have a history of known intolerance to the angiotensin II receptor antagonist. • (If you are a woman) Being pregnant or breastfeeding. (All patients who become pregnant during the study should discontinue the study therapy and inform the Clinical Monitor immediately). • Have a systolic blood pressure in the supine, sitting or standing position 2.5 mg / dL (> 220 fimol / L), or serum potassium 5.7 mEq / L ( 5.7 mmol / L) or TGOS / TGPS (ALT / AST) 3 times higher than the normal upper limit or blood hemoglobin (males and females <10 g / dL (6.206 mmol / L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cardiovascular mortality will include cardiac mortality and deaths from other vascular causes Measure:Combined ratio of death events from any cause and / or hospitalization due to heart failure Timepoints:When death ocurrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Cardiovascular mortality will include cardiac mortality and deaths from other vascular causes Measure:Combination of Death Due to Any Cause and / or Hospitalization for Any Reason Timepoints:When the event ocurrs ; Outcome name:Cardiovascular mortality will include cardiac mortality and deaths from other vascular causes Measure:Cardiovascular Mortality Timepoints:When the event ocurrs ; Outcome name:Hospitalization due to heart failure Measure:Hospitalization due to heart failure Timepoints:When the event occurs | — |
Countries
Belgium, Brazil, Chile, China, Colombia, Croatia, Egypt, France, Germany, Greece, Italy, Korea South, Lebano, Malasya, Mexico, Morocco, Netherlands, Norway, Peru, Philippines, Singapore, Slovenia, South Africa, Spain, Taiwan, Turkey
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed