Blood Pressure Reduction in Heart Failure (REPIC)

This study is not yet open for participant recruitment.
Verified December 2010 by University of Sao Paulo
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01255475
First received: December 6, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Sao Paulo:

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

Secondary Outcome Measures:
  • Cardiovascular death [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Acute myocardial ischemia [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Symptomatic hypotension [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Peak exercise oxygen consumption [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 12 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255475

Contacts
Contact: Victor S Issa, MD 551130695419 victor.issa@incor.usp.br
Contact: Silvia M Ayub-Ferreira, MD 551130695419 silvia.ayub@incor.usp.br

Locations
Brazil
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Not yet recruiting
São Paulo, SP, Brazil, 05403000
Contact: Victor S Issa, MD    551130695419    victor.issa@incor.usp.br   
Contact: Silvia M Ayub-Ferreira, MD    551130695419    silvia.ayub@incor.usp.br   
Principal Investigator: Edimar A Bocchi, Prof         
Sub-Investigator: Victor S Issa, MD         
Sub-Investigator: Silvia M Ayub-Ferreira, MD         
Sub-Investigator: Jeanne Tsutsui, MD         
Sub-Investigator: Guilherme V Guimarães, PhD         
Sub-Investigator: Alexandre C Pereira, MD         
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Edimar A Bocchi, Prof. Heart Institute (InCor) HC FMUSP
  More Information

No publications provided

Responsible Party: Edimar Alcides Bocchi, Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT01255475     History of Changes
Other Study ID Numbers: CNPq 474992/2009-8
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: Brazil: National Council for Ethics in Research (CONEP)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hydralazine
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014