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Blood Pressure Reduction in Heart Failure (REPIC)

Primary Purpose

Heart Failure, Cardiac Failure, Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Hydralazine/amlodipine
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Any cause mortality
Unplanned hospital admission from any cause

Secondary Outcome Measures

Cardiovascular death
Acute myocardial ischemia
Stroke
Symptomatic hypotension
Renal function
Peak exercise oxygen consumption
Quality of life

Full Information

First Posted
December 6, 2010
Last Updated
June 6, 2014
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01255475
Brief Title
Blood Pressure Reduction in Heart Failure
Acronym
REPIC
Official Title
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Failure, Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydralazine/amlodipine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo
Primary Outcome Measure Information:
Title
Any cause mortality
Time Frame
12 months after randomization
Title
Unplanned hospital admission from any cause
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Cardiovascular death
Time Frame
12 months after randomization
Title
Acute myocardial ischemia
Time Frame
12 months after randomization
Title
Stroke
Time Frame
12 months after randomization
Title
Symptomatic hypotension
Time Frame
12 months after randomization
Title
Renal function
Time Frame
12 months after randomization
Title
Peak exercise oxygen consumption
Time Frame
12 months after randomization
Title
Quality of life
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edimar A Bocchi, Prof.
Organizational Affiliation
Heart Institute (InCor) HC FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Blood Pressure Reduction in Heart Failure

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