Blood Pressure Reduction in Heart Failure (REPIC)
This study has been completed.
Sponsor:
University of Sao Paulo
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
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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:
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Hydralazine
Hydralazine hydrochloride
Amlodipine
Amlodipine besylate
U.S. FDA Resources
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
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 Cardiovascular Diseases Heart Diseases Amlodipine Hydralazine Antihypertensive Agents Calcium Channel Blockers |
Cardiovascular Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on February 25, 2015