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

NCT00763867

Last updated date
Study Location
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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%

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: Placebo
    Other Name: Sugar pill to mimic Sildenafil
  • Drug: Sildenafil
    Other Name: Active Sildenafil
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
    Intervention: Drug: Placebo
  • Experimental: Sildenafil
    Sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
    Intervention: Drug: Sildenafil
Publications *

*   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
 (submitted: July 2, 2013)
216
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
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:

  • 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%

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Kerry L. Lee, PhDDuke Clinical Research Institute
Study Chair:Eugene Braunwald, MDHarvard University
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