Heart FailureSTRETCHNCT01403714
Study of Percutaneous Renal Artery Intervention for Patient With Heart Failure
A study testing Renal Artery Stenting in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Renal Artery Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Trial of Percutaneous Renal Intervention With Stenting for Patients With Heart Failure and Hemodynamically Significant Renal Artery Stenosis
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.
- Conditions
- Heart Failure
- Being tested
- Renal Artery Stenting
- Keywords
- acute heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery StentingProcedure or surgery
If the patient has a hemodynamically significant renal artery stenosis, and they are randomized to renal artery stenting, they will undergo renal artery stenting
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | No intervention | Patients may be randomized to medical management alone |
| Renal Artery Stenting | Active comparator | 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 Receives: Procedure: Renal Artery Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart failure
The primary outcome will be the incidence of cardiac mortality or readmission for heart failure after one year.
Measured: one year
Secondary outcomes (1)
hospitalizations
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.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Inability to recruit eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wilensky, M.D., Principal investigator, University of PennsylvaniaZachary Gertz, M.D, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403714
- Sponsor's protocol ID
- 813650
- Acronym
- STRETCH
- Status last verified
- Mar 2012
- First submitted
- 21 Jul 2011
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Percutaneous Renal Intervention With Stenting for Patients With Heart Failure and Hemodynamically Significant Renal Artery Stenosis
- ClinicalTrials.gov ID
- NCT01403714
- Acronym / sponsor ID
- STRETCH / 813650
- Conditions
- Heart Failure
- Keywords
- acute heart failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit eligible subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Management | No intervention | –Patients may be randomized to medical management alone |
| Renal Artery Stenting | Active comparator | Procedure: Renal Artery StentingThose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Artery StentingIf the patient has a hemodynamically significant renal artery stenosis, and they are randomized to renal artery stenting, they will undergo renal artery stenting | Procedure or surgery | Renal Artery Stenting |
Primary outcome
heart failure
Time frame: one year
The primary outcome will be the incidence of cardiac mortality or readmission for heart failure after one year.
1 secondary outcome
hospitalizations
Time frame: five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wilensky, M.D. principal investigator
University of Pennsylvania
Zachary Gertz, M.D study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Artery Stenting in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart failure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.