Skip to main content
OpenTrials
Completed

NCT Number: NCT01255475

Blood Pressure Reduction in Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiac Failure Cardiovascular Diseases Congestive Heart Failure Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydralazine/amlodipine

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

Placebo

Drug

Patients will receive placebo

Primary outcomes

  1. Any cause mortality

    Time frame: 12 months after randomization

  2. Unplanned hospital admission from any cause

    Time frame: 12 months after randomization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Acronym: REPIC

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 7, 2010
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.