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Blood Pressure Reduction in Heart Failure (REPIC)

This study has been completed.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Edimar Alcides Bocchi, University of Sao Paulo Identifier:
First received: December 6, 2010
Last updated: June 6, 2014
Last verified: June 2014
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.

Condition Intervention Phase
Heart Failure Cardiac Failure Congestive Heart Failure Drug: Hydralazine/amlodipine Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:

Further study details as provided by Edimar Alcides Bocchi, University of Sao Paulo:

Primary Outcome Measures:
  • Any cause mortality [ Time Frame: 12 months after randomization ]
  • Unplanned hospital admission from any cause [ Time Frame: 12 months after randomization ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention 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
Placebo Comparator: Control Drug: Placebo
Patients will receive placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01255475

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Edimar A Bocchi, Prof. Heart Institute (InCor) HC FMUSP
  More Information

Responsible Party: Edimar Alcides Bocchi, Heart Failure Team Directos, University of Sao Paulo Identifier: NCT01255475     History of Changes
Other Study ID Numbers: CNPq 474992/2009-8
Study First Received: December 6, 2010
Last Updated: June 6, 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on September 21, 2017