Cardiac Failure, Congestive Heart Failure, Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGHydralazine/amlodipine
Patients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day
DRUGPlacebo
Patients will receive placebo
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any cause mortality | 12 months after randomization |
| Unplanned hospital admission from any cause | 12 months after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Stroke | 12 months after randomization |
| Symptomatic hypotension | 12 months after randomization |
| Cardiovascular death | 12 months after randomization |
| Peak exercise oxygen consumption | 12 months after randomization |
| Quality of life | 12 months after randomization |
| Renal function | 12 months after randomization |
| Acute myocardial ischemia | 12 months after randomization |
Countries
Brazil
Outcome results
None listed