Study of Renal Denervation in Patients With Heart Failure

Stopped early · Phase 2

Conditions studied: Heart Failure

In brief

Congestive heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Poor sodium handling by the kidneys is a damaging effect of heart failure, and it leads to symptoms of congestion such as shortness of breath or ankle swelling. Recent studies suggest that reducing the nerve activity to a kidney could reduce sodium retention and blood pressure. An improvement in the way the kidneys handle sodium may reduce disease progression and decrease symptoms for heart failure patients.

Key facts

Study ID

NCT01954160

Run by

Adrian Hernandez

People needed

5

Starts

2013-12-01

Expected to finish

2014-12-01

Last updated by the study team

2016-02-02

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 21-80 years old.
• History of chronic HF (>6 months) with current NYHA II-III symptoms.
• Left Ventricular Ejection Fraction ≤40% on a clinically indicated echocardiogram obtained within 6 months prior to informed consent.
• Requires daily loop diuretic (≥40mg furosemide per day, or equivalent) to maintain euvolemia (absence of congestive signs including jugular venous distension with Jugular Venous Pressure > 7cm H20, ≥ moderate (2+) peripheral edema, S3).
• Optimized medical therapy for HF. Patients will be receiving guideline-recommended therapy (per the 2013 ACCF/AHA HF Guidelines) including angiotensin-converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker, beta-blockers, and aldosterone antagonists without changes in heart failure medication regimen (including diuretics) for previous 14 days.
• Systolic blood pressure (BP) ≥110 mmHg at time of informed consent.
• Able to maintain stable medications for 52 weeks.
• Suitable renal artery anatomy for Renal Sympathetic Denervation (RSD) procedure. All of the following criteria must be met, based on the screening renal Doppler ultrasound:
• ≥ 20mm treatable length in each renal artery,
• Diameter in treatable segments must be ≥4mm,
• Lone main renal vessel feeding each kidney.

You may not qualify if…

• Unable to comply with protocol or procedures.
• Evidence of orthostatic hypotension or known dysautonomia. Orthostatic hypotension is defined by ≥1 of the following feature(s) within 2-5 minutes of quiet standing:
• ≥ 20 mmHg fall in systolic pressure
• ≥ 10 mmHg fall in diastolic pressure
• Symptoms of cerebral hypoperfusion (e.g. dizziness or lightheadedness, visual blurring or darkening of the visual fields, syncope).
• Evidence of or history of renal artery stenosis, nephrectomy, or renal transplant.
• Significant renal impairment as defined by estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 determined by Modification of Diet in Renal Disease (MDRD) equation.
• Significant proteinuria (>2g protein/daily protein excretion).
• Body mass index (BMI) >35 kg/m2.
• Acute coronary syndrome within last 4 weeks as defined by ECG changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or angina equivalent).
• Coronary revascularization procedures (percutaneous coronary intervention or cardiac artery bypass graft) and or valve surgery within 30 days of screening or expected procedures within the next 6 months.
• Cardiac resynchronization therapy, with or without implantable cardiac defibrillator within 90 days of screening or expected procedures within the next 6 months.
• Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, active myocarditis, active endocarditis, or complex congenital heart disease.
• Severe advanced HF, with ANY of the following features:
• Current or anticipated use of ventricular assist device within the next 6 months.
• Current or anticipated IV vasoactive drug therapy for HF management within the next 6 months.
• Listed cardiac transplant candidate, with transplantation likely within the next 6 months.
• Known allergic reactions to iodinated radiological contrast media or iodinated antiseptics.
• Greater than moderate mitral or aortic stenosis, and/or severe tricuspid regurgitation.
• Terminal illness (other than HF) with expected survival of less than 1 year.
• Female who is pregnant, nursing, or of childbearing potential not practicing effective birth control.
• Enrollment or planned enrollment in another clinical trial within the next 12 months.
• History of urinary outflow tract obstruction, bladder retention and/ or moderate to severe prostate hypertrophy.
• History of adrenal insufficiency
• History of untreated hypothyroidism

Where it is running

• Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Metro Health System — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The University of Vermont - Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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