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Clinical Trials/NCT01255475
NCT01255475
Completed
Phase 2

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

University of Sao Paulo1 site in 1 country21 target enrollmentJanuary 2011
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ConditionsHeart FailureCardiac FailureCongestive Heart Failure
InterventionsHydralazine/amlodipinePlacebo
DrugsHydralazine/amlodipinePlacebo

Overview

Phase
Phase 2
Intervention
Hydralazine/amlodipine
Conditions
Heart Failure
Sponsor
University of Sao Paulo
Enrollment
21
Locations
1
Primary Endpoint
Any cause mortality
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Edimar Alcides Bocchi

Heart Failure Team Directos

University of Sao Paulo

Eligibility 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

Arms & Interventions

Intervention

Intervention: Hydralazine/amlodipine

Control

Intervention: Placebo

Outcomes

Primary Outcomes

Any cause mortality

Time Frame: 12 months after randomization

Unplanned hospital admission from any cause

Time Frame: 12 months after randomization

Secondary Outcomes

  • 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)
  • Peak exercise oxygen consumption(12 months after randomization)
  • Quality of life(12 months after randomization)

Study Sites (1)

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