Blood Pressure Reduction in Heart Failure (REPIC)

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Edimar Alcides Bocchi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01255475
First received: December 6, 2010
Last updated: June 6, 2014
Last verified: June 2014

December 6, 2010
June 6, 2014
January 2011
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01255475 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Blood Pressure Reduction in Heart Failure
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Cardiac Failure
  • Congestive Heart Failure
  • 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
  • Drug: Placebo
    Patients will receive placebo
  • Experimental: Intervention
    Intervention: Drug: Hydralazine/amlodipine
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01255475
CNPq 474992/2009-8
Yes
Edimar Alcides Bocchi, University of Sao Paulo
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Edimar A Bocchi, Prof. Heart Institute (InCor) HC FMUSP
University of Sao Paulo
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP