Blood Pressure Reduction in Heart Failure (REPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255475
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 10, 2014
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Edimar Alcides Bocchi, University of Sao Paulo

December 6, 2010
December 7, 2010
June 10, 2014
January 2011
October 2012   (Final data collection date for primary outcome measure)
  • Any cause mortality [ Time Frame: 12 months after randomization ]
  • Unplanned hospital admission from any cause [ Time Frame: 12 months after randomization ]
Same as current
Complete list of historical versions of study NCT01255475 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Blood Pressure Reduction in Heart Failure
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Cardiac Failure
  • Congestive Heart Failure
  • Drug: Hydralazine/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
  • Drug: Placebo
    Patients will receive placebo
  • Experimental: Intervention
    Intervention: Drug: Hydralazine/amlodipine
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CNPq 474992/2009-8
Not Provided
Not Provided
Edimar Alcides Bocchi, University of Sao Paulo
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Edimar A Bocchi, Prof. Heart Institute (InCor) HC FMUSP
University of Sao Paulo
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP