Blood Pressure Reduction in Heart Failure (REPIC)

University of Sao Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cardiac Failure; Heart Failure; Congestive Heart Failure

Treatments: Drug: Placebo; Drug: Hydralazine/amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01255475

CNPq 474992/2009-8

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Treatment:

Drug: Hydralazine/amlodipine

Control

Placebo Comparator group

Treatment:

Drug: Placebo