Blood Pressure Reduction in Heart Failure

NCT ID: NCT01255475

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Cardiac Failure Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention

Group Type EXPERIMENTAL

Hydralazine/amlodipine

Intervention Type DRUG

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

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive placebo

Interventions

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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

Intervention Type DRUG

Placebo

Patients will receive placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Edimar Alcides Bocchi

Heart Failure Team Directos

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edimar A Bocchi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor) HC FMUSP

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CNPq 474992/2009-8

Identifier Type: -

Identifier Source: org_study_id

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