Losartan in Decompensated Heart Failure
Avainsanat
Abstrakti
Kuvaus
The inclusion criteria were hospitalization for decompensated heart failure defined by worsening of symptoms until fatigue or dyspnea at rest, low cardiac output defined by the clinical-hemodynamic profile, dobutamine dependence, and ejection fraction < 0.45, spontaneous breathing and receiving angiotensin-converting enzyme inhibitors. The patients could have jugular ingurgitation, lower limbs edema, ascites and rales. Dobutamine dependence was defined by infusion for more than 15 days or an unsuccessful attempt of withdrawal.
The exclusion criteria were serum creatinine > 3.0 mg/dL, serum potassium > 6.0 mEq/L, systolic blood pressure < 70 mm Hg, aortic stenosis, and acute coronary syndrome in the previous 2 months. The patients were randomly assigned by permuted block of 4, stratified by sex, to losartan or placebo.
The endpoints were change in B-type natriuretic peptide levels, cardiac index, pulmonary wedge capillary pressure, systemic vascular resistance, and successful withdrawal of dobutamine.
Päivämäärät
| Viimeksi vahvistettu: | 02/28/2011 |
| Ensimmäinen lähetys: | 05/15/2013 |
| Arvioitu ilmoittautuminen lähetetty: | 05/16/2013 |
| Ensimmäinen lähetetty: | 05/19/2013 |
| Viimeisin päivitys lähetetty: | 05/16/2013 |
| Viimeisin päivitys lähetetty: | 05/19/2013 |
| Todellinen opintojen alkamispäivä: | 08/31/2008 |
| Arvioitu ensisijainen valmistumispäivä: | 01/31/2011 |
| Arvioitu tutkimuksen valmistumispäivä: | 02/28/2011 |
Ehto tai tauti
Interventio / hoito
Drug: Losartan
Drug: Placebo
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Experimental: Losartan Losartan 50 mg bid orally | Drug: Losartan |
| Placebo Comparator: Placebo Placebo 1 pill bid orally | Drug: Placebo |
Kelpoisuusehdot
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: - hospitalization for decompensated heart failure - dobutamine dependence - ejection fraction < 0.45 - taking angiotensin-converting enzyme inhibitor Exclusion Criteria: - serum creatinine > 3.0 mg/dL - serum potassium > 6.0 mEq/L - systolic blood pressure < 70 mm Hg - aortic stenosis - acute coronary syndrome in the previous 2 months |
Tulokset
Ensisijaiset tulosmittaukset
1. B-type natriuretic peptide [7 days]
Toissijaiset tulosmittaukset
1. Successful withdrawal from dobutamine [7 days]
2. Worsening renal function [7 days]
3. Hyperkalemia [7 days]
4. Hypotension [7 days]
