Blood Pressure Reduction in Heart Failure

Condition(s) targeted: Heart Failure; Cardiac Failure; Congestive Heart Failure

Intervention: Hydralazine/amlodipine (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Edimar A Bocchi, Prof., Principal Investigator, Affiliation: Heart Institute (InCor) HC FMUSP

Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.

Official title: Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Any cause mortality

Unplanned hospital admission from any cause

Secondary outcome:

Cardiovascular death

Acute myocardial ischemia

Stroke

Symptomatic hypotension

Renal function

Peak exercise oxygen consumption

Quality of life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- stable chronic heart failure for at least 6 months

- ejection fraction of 40% or less, as measured by transthoracic echocardiography

- optimal clinical treatment for chronic heart failure according to current

international guidelines. Exclusion Criteria:

- patient refusal

- rheumatic or degenerative valvular disease

- restrictive cardiomyopathy

- evidence of myocardial ischemia

- alcohol or drug use

- malignant neoplasm

- active infection

- surgical intervention in the 3 previous months

- lactation, childbearing or childbearing potential.

- pulmonary embolism in the 6 previous months

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP 05403000, Brazil

Starting date: January 2011
Last updated: June 6, 2014