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Blood Pressure Reduction in Heart Failure (REPIC)

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ClinicalTrials.gov Identifier: NCT01255475
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 10, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : January 2011
Primary Completion Date : October 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 12 months after randomization ]
  2. Acute myocardial ischemia [ Time Frame: 12 months after randomization ]
  3. Stroke [ Time Frame: 12 months after randomization ]
  4. Symptomatic hypotension [ Time Frame: 12 months after randomization ]
  5. Renal function [ Time Frame: 12 months after randomization ]
  6. Peak exercise oxygen consumption [ Time Frame: 12 months after randomization ]
  7. Quality of life [ Time Frame: 12 months after randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255475


Locations
Brazil
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01255475     History of Changes
Other Study ID Numbers: CNPq 474992/2009-8
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

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