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Study of Percutaneous Renal Artery Intervention for Patient With Heart Failure (STRETCH)

This study has been withdrawn prior to enrollment.
(Inability to recruit eligible subjects)
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01403714
First received: July 21, 2011
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose
This study will address the role of percutaneous renal intervention for a hemodynamically significant renal artery stenosis in patients with heart failure exacerbations. Current guidelines suggest evaluation for renal artery stenosis in patients with pulmonary edema or heart failure that cannot be attributed to poor left ventricular function. While case series have suggested benefit to percutaneous intervention in patients with heart failure, no randomized study has addressed the potential benefit of renal stenting for heart failure patients. Two large randomized trial of renal stenting for hypertension or poor kidney function failed to show benefit in patients with intermediate renal artery lesions. No evaluation of the potential hemodynamic significance of the lesions was performed prior to randomization. The investigators will enroll patients with heart failure exacerbations not attributable to declining left ventricular function, valvular disease, acute coronary syndrome, or heart transplant rejection, who on non-invasive imaging appear to have renal artery stenosis. After routine invasive assessment, including renal angiography and pressure-wire assessment, patients with hemodynamically significant renal artery stenoses will be randomized to stent implantation or medical therapy. Patients will then be followed to determine whether stenting impacts cardiac mortality or hospitalization for heart failure.

Condition Intervention
Heart Failure
 Procedure: Renal Artery Stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Percutaneous Renal Intervention With Stenting for Patients With Heart Failure and Hemodynamically Significant Renal Artery Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • heart failure [ Time Frame: one year ] [ Designated as safety issue: No ]
    The primary outcome will be the incidence of cardiac mortality or readmission for heart failure after one year.


Secondary Outcome Measures:
  • hospitalizations [ Time Frame: five years ] [ Designated as safety issue: No ]
    Secondary analyses will include all-cause mortality, all hospitalizations, changes in echocardiographic parameters, changes in heart failure class, changes in renal function, and changes in blood pressure.
Enrollment: 0
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Medical Management
Patients may be randomized to medical management alone
Active Comparator: Renal Artery Stenting
Those patients with recent heart failure exacerbations that cannot be attributed to poor left ventricular function and have a hemodynamically significant renal artery stenosis may be randomized to renal artery stenting
 Procedure: Renal Artery Stenting
If the patient has a hemodynamically significant renal artery stenosis, and they are randomized to renal artery stenting, they will undergo renal artery stenting

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 or older referred for invasive evaluation of possible renal artery stenosis will be screened for enrollment.

Patients must be inpatients admitted for heart failure exacerbation, or have been admitted to a hospital for heart failure exacerbation within the past 90 days. Heart failure is defined as physician documentation or report of any of the following clinical symptoms of heart failure described as dyspnea on exertion, dyspnea occurring in the supine position, fluid retention; or the description of rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray; without being clearly attributable to liver, kidney, or lung disease. Patients must have one of the following: 1. an ejection fraction of 50%; 2. an ejection fraction of 25-50% in the setting of a systolic blood pressure of at least 160 mmHg; or 3. an ejection fraction of 25-50% and a systolic blood pressure of at least 140 mmHg while being treated with at least 2 antihypertensive medications. Patients who meet these criteria and have a proven hemodynamically significant renal artery stenosis (as described in the procedure section) will be included

Exclusion Criteria:

Patients with heart failure from structural heart disease (including greater than moderate dysfunction of the mitral or aortic valve), acute coronary syndrome, post-partum cardiomyopathy, or acute rejection of a transplanted heart will be excluded. Patients who are considered unlikely to survive to hospital discharge will be excluded. Patients with fibromuscular dysplasia, prior renal stenting, or anatomy unsuitable for renal stenting (i.e. prior vascular surgery making stent delivery impossible) will be excluded. Patients who are unable to take aspirin and clopidogrel will be excluded. Patients with a creatinine clearance <30 mL/min or a history of renal transplantation will be excluded. Pregnant women will be excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403714

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert Wilensky, M.D. University of Pennsylvania
Study Director: Zachary Gertz, M.D University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01403714     History of Changes
Other Study ID Numbers: 813650 
Study First Received: July 21, 2011
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
acute heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016