Blood Pressure Reduction in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Heart Failure, Cardiac Failure, Congestive Heart Failure

Intervention / Treatment
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* Drug: Hydralazine/amlodipine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Drug: Hydralazine/amlodipine<br>* 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<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* Patients will receive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any cause mortality |  | 12 months after randomization | 
| Unplanned hospital admission from any cause |  | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | 12 months after randomization | 
| Acute myocardial ischemia |  | 12 months after randomization | 
| Stroke |  | 12 months after randomization | 
| Symptomatic hypotension |  | 12 months after randomization | 
| Renal function |  | 12 months after randomization | 
| Peak exercise oxygen consumption |  | 12 months after randomization | 
| Quality of life |  | 12 months after randomization |