Blood Pressure Reduction in Heart Failure
REPIC
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 heart-failure
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 10, 2014
June 1, 2014
1.8 years
December 6, 2010
June 6, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Any cause mortality
12 months after randomization
Unplanned hospital admission from any cause
12 months after randomization
Secondary Outcomes (7)
Cardiovascular death
12 months after randomization
Acute myocardial ischemia
12 months after randomization
Stroke
12 months after randomization
Symptomatic hypotension
12 months after randomization
Renal function
12 months after randomization
- +2 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edimar A Bocchi, Prof.
Heart Institute (InCor) HC FMUSP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Heart Failure Team Directos
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 7, 2010
Study Start
January 1, 2011
Primary Completion
October 1, 2012
Study Completion
January 1, 2013
Last Updated
June 10, 2014
Record last verified: 2014-06