Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)
NCT00763867
ABOUT THIS STUDY
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- Previous clinical diagnosis of heart failure with current New York Heart Association (NYHA) Class II-IV symptoms
- Has experienced at least one of the following in the 12 months before study entry:
- Hospitalization for decompensated heart failure
- Acute treatment with intravenous loop diuretic or hemofiltration
- Mean pulmonary capillary wedge pressure greater than 15 mm Hg or left ventricular end diastolic pressure (LVEDP) greater than 18 mm Hg at catheterization for dyspnea
- Long term treatment with a loop diuretic and chronic diastolic dysfunction on echocardiography, as determined by left atrial enlargement
- Left ventricular ejection fraction greater than or equal to 50%, as determined by a clinical echocardiogram or ventriculogram in the 12 months before study entry
- Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%
- Has a neuromuscular, orthopedic, or other non-cardiac condition that prevents
individual from exercise testing on a bicycle ergometer or from walking in a hallway
- Non-cardiac condition that limits life expectancy to less than 1 year at the time of
study entry, based on the judgment of the physician
- Current or anticipated future need for nitrate therapy
- Valve disease (i.e., greater than mild aortic or mitral stenosis; greater than
moderate aortic or mitral regurgitation)
- Hypertrophic cardiomyopathy
- Infiltrative or inflammatory myocardial disease (e.g., amyloid, sarcoid)
- Pericardial disease
- Primary pulmonary arteriopathy
- Has experienced a heart attack or unstable angina, or has undergone percutaneous
transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) in
the 60 days before study entry, or requires either PTCA or CABG at the time of study
entry
- Other clinically important causes of dyspnea, such as morbid obesity or significant
lung disease, as defined by clinical judgment or use of steroids or oxygen for lung
disease
- Systolic blood pressure less than 110 mm Hg or greater than 180 mm Hg
- Diastolic blood pressure less than 40 mm Hg or greater than 100 mm Hg
- Resting heart rate (HR) greater than 100 bpm
- History of reduced ejection fraction (less than 50%)
- Implanted metallic device that will interfere with MRI examination (in people without
atrial fibrillation)
- Severe kidney dysfunction (estimated glomerular filtration rate [GFR] less than 20
ml/min/1.73m2 by modified modification of diet in renal disease [MDRD] equation)
- Pregnant or not using an effective form of contraception
- Hemoglobin level of less than 10 g/dL
- Taking alpha antagonists or cytochrome P450 3A4 inhibitors (e.g., ketoconazole,
itraconazole, erythromycin, saquinavir, cimetidine, or serum protease inhibitors for
HIV)
- Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated
proliferative retinopathy, or unexplained visual disturbance
- Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase
the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease)
- Severe liver disease (aspartate aminotransferase [AST] level greater than three times
the normal limit, alkaline phosphatase or bilirubin greater than two times the normal
limit)
- In being consistent with American College of Cardiology (ACC)/American Heart
Association (AHA) guidelines, people with dyspnea and risk factors for coronary artery
disease should have had a stress test and those people with a clinically indicated
stress test demonstrating significant ischemia in the 1 year before study entry will
be excluded.
- Listed for heart transplantation
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Descriptive Information | |||||||
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Brief Title ICMJE | Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) | ||||||
Official Title ICMJE | Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX) | ||||||
Brief Summary | 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. | ||||||
Detailed Description | 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Heart Failure | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 216 | ||||||
Original Estimated Enrollment ICMJE | 190 | ||||||
Actual Study Completion Date ICMJE | September 2012 | ||||||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00763867 | ||||||
Other Study ID Numbers ICMJE | Pro00018007 U01HL084904 ( U.S. NIH Grant/Contract ) U01HL084904-01 ( U.S. NIH Grant/Contract ) 521 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Duke University | ||||||
Study Sponsor ICMJE | Duke University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Duke University | ||||||
Verification Date | July 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |