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
  Purpose

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 Intervention Phase
Heart Failure
Cardiac Failure
Congestive Heart Failure
Drug: Hydralazine/amlodipine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 6, 2010
Last Updated: June 6, 2014
Health Authority: Brazil: National Council for Ethics in Research (CONEP)

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

ClinicalTrials.gov processed this record on September 16, 2014