Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2008
End Date:March 2010

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Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX)


Diastolic heart failure (DHF), which affects older individuals and women at a
disproportionate rate, is a condition that can lead to shortness of breath and fluid
build-up in the lungs. This study will evaluate the effectiveness of the medication
sildenafil at improving exercise ability and health outcomes in people with DHF.


DHF is a condition in which one of the chambers of the heart, the left ventricle, loses its
ability to relax completely because the muscle has become too stiff. When this occurs, the
heart is unable to properly fill with blood, which can lead to decreased blood circulation.
People with DHF may experience shortness of breath and pulmonary congestion, which is an
abnormal build-up of fluid in the lungs. Current treatment for DHF includes
guidelines/recommendations to lower blood pressure, stop smoking, and lose weight, but there
are no medications available to specifically treat DHF. Sildenafil, commonly known as
Revatio or Viagra, is a medication that increases the supply of blood to the lungs and
reduces the workload of the heart. Preliminary studies have shown that sildenafil may be
beneficial at improving heart and lung function in people with DHF, but more research is
needed to confirm these findings. The purpose of this study is to determine if sildenafil
can improve exercise ability and health outcomes in people with DHF.

This 24-week study will enroll people with DHF. Participants will be randomly assigned to
receive either sildenafil or placebo three times a day for 24 weeks. Participants will
attend study visits at baseline and Weeks 1, 4, 12, 13, and 24. At most study visits, the
following procedures will occur: physical exam, medical history review, questionnaires,
blood collection, 6-minute walk test to measure endurance, and an exercise test. At baseline
and Week 24, participants will also undergo an electrocardiogram, which will measure the
electrical activity of the heart, and a cardiac magnetic resonance imaging (MRI) procedure
and an echocardiogram, which will both obtain pictures of the heart. At Weeks 3, 8, 16, and
20, study researchers will call participants to collect health information.


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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Atlanta, Georgia 30310
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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850 Boylston Street
Chestnut Hill, Massachusetts 02467
1-800-BWH-9999
Brigham & Women's Hospital Women's Health Center At Brigham and Women
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1 Baylor Plaza
Houston, Texas 77030
(713) 798-4951
Baylor School of Medicine Baylor College of Medicine is a health sciences university that creates...
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Houston, TX
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Minneapolis, Minnesota 55415
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Salt Lake City, Utah 84132
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