A Phase 2/3 interventional study of Hydralazine/amlodipine and Placebo in Heart Failure, Cardiac Failure and Congestive Heart Failure, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-10.
Sponsored by University of Sao Paulo · Phase 2/3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 21 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Hydralazine/amlodipine
Drug: Placebo
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
Patients will receive placebo
Any cause mortality
Time frame: 12 months after randomization
Unplanned hospital admission from any cause
Time frame: 12 months after randomization
Cardiovascular death
Time frame: 12 months after randomization
Acute myocardial ischemia
Time frame: 12 months after randomization
Stroke
Time frame: 12 months after randomization
Symptomatic hypotension
Time frame: 12 months after randomization
Renal function
Time frame: 12 months after randomization
Peak exercise oxygen consumption
Time frame: 12 months after randomization
Quality of life
Time frame: 12 months after randomization
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sao Paulo