Blood Pressure Reduction in Heart Failure (REPIC)
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ClinicalTrials.gov Identifier: NCT01255475 |
Recruitment Status
:
Completed
First Posted
: December 7, 2010
Last Update Posted
: June 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Cardiac Failure Congestive Heart Failure | Drug: Hydralazine/amlodipine Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
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
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Placebo Comparator: Control |
Drug: Placebo
Patients will receive placebo
|
- Any cause mortality [ Time Frame: 12 months after randomization ]
- Unplanned hospital admission from any cause [ Time Frame: 12 months after randomization ]
- Cardiovascular death [ Time Frame: 12 months after randomization ]
- Acute myocardial ischemia [ Time Frame: 12 months after randomization ]
- Stroke [ Time Frame: 12 months after randomization ]
- Symptomatic hypotension [ Time Frame: 12 months after randomization ]
- Renal function [ Time Frame: 12 months after randomization ]
- Peak exercise oxygen consumption [ Time Frame: 12 months after randomization ]
- Quality of life [ Time Frame: 12 months after randomization ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255475
Brazil | |
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | |
São Paulo, SP, Brazil, 05403000 |
Principal Investigator: | Edimar A Bocchi, Prof. | Heart Institute (InCor) HC FMUSP |
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 |
First Posted: | December 7, 2010 Key Record Dates |
Last Update Posted: | June 10, 2014 |
Last Verified: | June 2014 |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases Amlodipine Hydralazine |
Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents |