Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) (RELAX)
2014년 7월 14일 업데이트: Duke University
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
216
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85054
- Mayo Clinic Arizona
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Georgia
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Atlanta, Georgia, 미국, 30310
- Morehouse School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55415
- Minnesota Heart Failure Network
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Utah
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Murray, Utah, 미국, 84107
- University of Utah Health Sciences Center
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Vermont
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Burlington, Vermont, 미국, 05401
- University of Vermont - Fletcher Allen Health Care
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Quebec
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Montreal, Quebec, 캐나다, H1T - 1C8
- Montreal Heart Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Placebo
Placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
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다른 이름들:
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실험적: Sildenafil
Sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Exercise Capacity, as Determined by Peak Oxygen Uptake
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exercise Capacity, as Determined by Peak Oxygen Uptake
기간: Change from Baseline to Week 12
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Change from Baseline to Week 12
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Exercise Capacity as Determined by Walk Distance
기간: Change from Baseline to Week 12
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6 Minute Walk Distance
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Change from Baseline to Week 12
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Composite Score Reflective of Clinical Status
기간: Measured at Week 24
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Participants ranked sequentially with ranking stratified in one of three tiers based on:
The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better) |
Measured at Week 24
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Exercise Capacity as Determined by Walk Distance
기간: Change from Baseline to Week 24
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6 minute walk distance
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Change from Baseline to Week 24
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Cardiopulmonary Exercise Test (CPET) Duration
기간: Change from Baseline to Week 12
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To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement
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Change from Baseline to Week 12
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Cardiopulmonary Exercise Test (CPET) Duration
기간: Change from Baseline to Week 24
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To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement
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Change from Baseline to Week 24
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Ventilatory Anaerobic Threshold
기간: Change from Baseline to Week 12
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To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement
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Change from Baseline to Week 12
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Ventilatory Anaerobic Threshold
기간: Change from Baseline to Week 24
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To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement
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Change from Baseline to Week 24
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Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
기간: Change from Baseline to Week 12
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The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment. Total score: 0 - 105 Physical subscore: 0 - 40 Emotional subscore: 0 - 25 |
Change from Baseline to Week 12
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Minnesota Living With Heart Failure Questionnaire
기간: Change from Baseline to Week 24
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The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life.
Patients respond to 21 items using a six-point response scale (0-5).
The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.
Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.
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Change from Baseline to Week 24
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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MRI Left Ventricular Mass
기간: Change from Baseline to Week 24
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A decrease in LV Mass is considered an improvement
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Change from Baseline to Week 24
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MRI Left Ventricular Mass Index
기간: Change from Baseline to Week 24
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A decrease in Left Ventricular Mass Index is considered an improvement
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Change from Baseline to Week 24
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MRI Left Ventricular End Diastolic Volume
기간: Change from Baseline to Week 24
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An increase in Left Ventricular End Diastolic Volume is considered an improvement
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Change from Baseline to Week 24
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MRI Left Ventricular End Diastolic Volume Index
기간: Change from Baseline to Week 24
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An increase in Left Ventricular End Diastolic Volume Index is considered an improvement
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Change from Baseline to Week 24
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MRI Left Ventricular End Systolic Volume Index
기간: Change from Baseline to Week 24
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An increase in Left Ventricular End Systolic Volume Index is considered an improvement
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Change from Baseline to Week 24
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MRI Left Ventricular Ejection Fraction (LVEF)
기간: Change from Baseline to Week 24
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An increase in LVEF is considered an improvement
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Change from Baseline to Week 24
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Echocardiogram Left Ventricular Mass
기간: Change from Baseline to Week 24
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A decrease in Left Ventricular Mass is considered an improvement
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Change from Baseline to Week 24
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Medial Diastolic Elastance
기간: Change from Baseline to Week 24
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A decrease in Medial Diastolic Elastance is considered an improvement
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Change from Baseline to Week 24
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Lateral Diastolic Elastance
기간: Change from Baseline to Week 24
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A decrease in Lateral Diastolic Elastance is considered an improvement
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Change from Baseline to Week 24
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Medial Left Ventricular Relaxation
기간: Change from Baseline to Week 24
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An increase in Left Ventricular relaxation is considered to be an improvement
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Change from Baseline to Week 24
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Lateral Left Ventricular Relaxation
기간: Change from Baseline to Week 24
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An increase in Left Ventricular relaxation is considered to be an improvement
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Change from Baseline to Week 24
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Medial Filling Pressure
기간: Change from Baseline to Week 24
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A decrease in medial filling pressure is considered an improvement
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Change from Baseline to Week 24
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Lateral Filling Pressure
기간: Change from Baseline to Week 24
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A decrease in lateral filling pressure is considered an improvement
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Change from Baseline to Week 24
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ECHO Effective Arterial Elastance
기간: Change from Baseline to Week 24
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A decrease in Effective Arterial Elastance is considered an improvement
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Change from Baseline to Week 24
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ECHO Systemic Vascular Resistance
기간: Change from Baseline to Week 24
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A decrease in Systemic Vascular Resistance is considered an improvement
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Change from Baseline to Week 24
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MRI Effective Arterial Elastance
기간: Change from Baseline to Week 24
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A decrease in Effective Arterial Elastance is considered an improvement
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Change from Baseline to Week 24
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MRI Systemic Vascular Resistance
기간: Change from Baseline to Week 24
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A decrease in Systemic Vascular Resistance is considered an improvement
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Change from Baseline to Week 24
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MRI Aortic Thickness
기간: Change from Baseline to Week 24
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A decrease in Aortic Thickness is considered an improvement
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Change from Baseline to Week 24
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MRI Aortic Distensibility
기간: Change from Baseline to Week 24
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An increase in Aortic Distensibility is considered to be an improvement
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Change from Baseline to Week 24
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ECHO Pulmonary Artery Systolic Pressure
기간: Change from Baseline to Week 24
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A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement
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Change from Baseline to Week 24
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Best Available Creatinine
기간: Change from Baseline to Week 24
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Best available=local lab results only when core lab results not available
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Change from Baseline to Week 24
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Best Available Glomerular Filtration Rate (GFR)
기간: Change from Baseline to Week 24
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Best available=local lab results when core lab results not available
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Change from Baseline to Week 24
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Cystatin C
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Uric Acid
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Aldosterone
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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High Sensitivity Troponin I
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Procollagen III N-terminal Peptide
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Endothelin-1
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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High Sensitivity C-Reactive Protein
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Collagen Type I (CITP)
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Cyclic Guanosine Monophosphate (cGMP)
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Galectin 3
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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Furosemide-Equivalent Dose
기간: Change from Baseline to Week 24
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Change from Baseline to Week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
- Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E; RELAX Trial. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA. 2013 Mar 27;309(12):1268-77. doi: 10.1001/jama.2013.2024.
- Bevan GH, Rana M, Al-Furaih N, Dalton J, Zidar DA, Al-Kindi SG. Anisocytosis is associated with myocardial fibrosis and exercise capacity in heart failure with preserved ejection fraction. Heart Lung. 2022 Jul-Aug;54:68-73. doi: 10.1016/j.hrtlng.2022.03.013. Epub 2022 Mar 28.
- Fudim M, Kelly JP, Jones AD, AbouEzzeddine OF, Ambrosy AP, Greene SJ, Reddy YNV, Anstrom KJ, Alhanti B, Lewis GD, Hernandez AF, Felker GM. Are existing and emerging biomarkers associated with cardiorespiratory fitness in patients with chronic heart failure? Am Heart J. 2020 Feb;220:97-107. doi: 10.1016/j.ahj.2019.11.006. Epub 2019 Nov 16.
- Reddy YNV, Lewis GD, Shah SJ, Obokata M, Abou-Ezzedine OF, Fudim M, Sun JL, Chakraborty H, McNulty S, LeWinter MM, Mann DL, Stevenson LW, Redfield MM, Borlaug BA. Characterization of the Obese Phenotype of Heart Failure With Preserved Ejection Fraction: A RELAX Trial Ancillary Study. Mayo Clin Proc. 2019 Jul;94(7):1199-1209. doi: 10.1016/j.mayocp.2018.11.037.
- AbouEzzeddine OF, McKie PM, Dunlay SM, Stevens SR, Felker GM, Borlaug BA, Chen HH, Tracy RP, Braunwald E, Redfield MM. Suppression of Tumorigenicity 2 in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2017 Feb 18;6(2):e004382. doi: 10.1161/JAHA.116.004382. Erratum In: J Am Heart Assoc. 2017 Sep 20;6(9):
- DeVore AD, McNulty S, Alenezi F, Ersboll M, Vader JM, Oh JK, Lin G, Redfield MM, Lewis G, Semigran MJ, Anstrom KJ, Hernandez AF, Velazquez EJ. Impaired left ventricular global longitudinal strain in patients with heart failure with preserved ejection fraction: insights from the RELAX trial. Eur J Heart Fail. 2017 Jul;19(7):893-900. doi: 10.1002/ejhf.754. Epub 2017 Feb 14.
- Hussain I, Mohammed SF, Forfia PR, Lewis GD, Borlaug BA, Gallup DS, Redfield MM. Impaired Right Ventricular-Pulmonary Arterial Coupling and Effect of Sildenafil in Heart Failure With Preserved Ejection Fraction: An Ancillary Analysis From the Phosphodiesterase-5 Inhibition to Improve Clinical Status And Exercise Capacity in Diastolic Heart Failure (RELAX) Trial. Circ Heart Fail. 2016 Apr;9(4):e002729. doi: 10.1161/CIRCHEARTFAILURE.115.002729.
- Lindman BR, Davila-Roman VG, Mann DL, McNulty S, Semigran MJ, Lewis GD, de las Fuentes L, Joseph SM, Vader J, Hernandez AF, Redfield MM. Cardiovascular phenotype in HFpEF patients with or without diabetes: a RELAX trial ancillary study. J Am Coll Cardiol. 2014 Aug 12;64(6):541-9. doi: 10.1016/j.jacc.2014.05.030.
- Mohammed SF, Borlaug BA, McNulty S, Lewis GD, Lin G, Zakeri R, Semigran MJ, LeWinter M, Hernandez AF, Braunwald E, Redfield MM. Resting ventricular-vascular function and exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail. 2014 Jul;7(4):580-9. doi: 10.1161/CIRCHEARTFAILURE.114.001192. Epub 2014 May 15.
- Zakeri R, Borlaug BA, McNulty SE, Mohammed SF, Lewis GD, Semigran MJ, Deswal A, LeWinter M, Hernandez AF, Braunwald E, Redfield MM. Impact of atrial fibrillation on exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail. 2014 Jan;7(1):123-30. doi: 10.1161/CIRCHEARTFAILURE.113.000568. Epub 2013 Oct 25.
- Redfield MM, Borlaug BA, Lewis GD, Mohammed SF, Semigran MJ, Lewinter MM, Deswal A, Hernandez AF, Lee KL, Braunwald E; Heart Failure Clinical Research Network. PhosphdiesteRasE-5 Inhibition to Improve CLinical Status and EXercise Capacity in Diastolic Heart Failure (RELAX) trial: rationale and design. Circ Heart Fail. 2012 Sep 1;5(5):653-9. doi: 10.1161/CIRCHEARTFAILURE.112.969071.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 9월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2012년 9월 1일
연구 등록 날짜
최초 제출
2008년 9월 30일
QC 기준을 충족하는 최초 제출
2008년 9월 30일
처음 게시됨 (추정)
2008년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 7월 14일
마지막으로 확인됨
2013년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00018007
- U01HL084904 (미국 NIH 보조금/계약)
- 521
- U01HL084904-01 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .