Ramipril for Intermittent Claudication
Recruiting in Palo Alto (17 mi)
Overseen ByIraklis I Pipinos, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Nebraska
Must not be taking: Ace inhibitors
Disqualifiers: Rest pain, Acute ischemic event, others
No Placebo Group
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if Ramipril can help patients with PAD who have severe leg pain walk better. Ramipril may improve muscle function by reducing damage and stiffness in the legs.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using ACE inhibitors or angiotensin II receptor blockers.
What data supports the effectiveness of the drug ramipril for intermittent claudication?
Research shows that ramipril can more than double the maximum walking times in patients with peripheral artery disease and intermittent claudication, improving their walking ability and quality of life.
12345Is ramipril generally safe for human use?
Ramipril is generally well tolerated in humans, with studies showing it is safe for treating high blood pressure and heart failure. It has a similar safety profile to other ACE inhibitors, with only about 5% of patients stopping treatment due to side effects.
13467How does the drug ramipril differ from other treatments for intermittent claudication?
Ramipril is unique because it not only helps improve walking ability in patients with intermittent claudication, but it also reduces the risk of cardiovascular events like heart attacks and strokes, which is not a common benefit of other treatments for this condition.
13458Eligibility Criteria
This trial is for individuals with Peripheral Artery Disease (PAD) who experience leg pain during walking due to claudication. They should have stable blood pressure, cholesterol, and diabetes management. Participants must not have severe kidney issues, a history of angioedema with ACE inhibitors, critical limb ischemia, or other conditions severely affecting their walking ability.Inclusion Criteria
You have a history of long-term leg pain while walking.
Stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
You have a history of leg pain that limits your ability to exercise, and this has been confirmed by a screening walking test administered by a vascular surgeon.
+1 more
Exclusion Criteria
You have a history of severe blockage in the arteries leading to your kidneys on both sides.
You have experienced angioedema from taking ACE inhibitors before, or you are allergic to ramipril or other ACE inhibitors.
You have severe pain or tissue loss caused by peripheral artery disease.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 6 months of treatment with the medication Ramipril
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if Ramipril can improve walking performance and quality of life in PAD patients by reducing muscle damage and fibrosis compared to standard treatments like cilostazol and pentoxifylline. It's hypothesized that Ramipril may help by decreasing oxidative damage in muscles.
1Treatment groups
Experimental Treatment
Group I: Ramipril TreatmentExperimental Treatment1 Intervention
6 months treatment with the medication Ramipril
Ramipril is already approved in United States, Canada, European Union, India for the following indications:
๐บ๐ธ Approved in United States as Altace for:
- High blood pressure
- Heart failure
- Diabetic kidney disease
- Prevention of heart attack, stroke, or cardiovascular death in high-risk patients
๐จ๐ฆ Approved in Canada as Altace for:
- High blood pressure
- Heart failure
- Diabetic kidney disease
๐ช๐บ Approved in European Union as Ramipril for:
- High blood pressure
- Heart failure
- Diabetic kidney disease
- Prevention of heart attack, stroke, or cardiovascular death in high-risk patients
๐ฎ๐ณ Approved in India as Cardace for:
- High blood pressure
- Heart failure
- Diabetic kidney disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Medical CenterOmaha, NE
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Who Is Running the Clinical Trial?
University of NebraskaLead Sponsor
References
Potential vascular mechanisms of ramipril induced increases in walking ability in patients with intermittent claudication. [2015]We recently reported that ramipril more than doubled maximum walking times in patients with peripheral artery disease with intermittent claudication.
Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial. Journal of the American Medical Association 2013; 309: 453-460. [2018]The objective of the trial was to examine whether ramipril, an angiotensin-converting enzyme (ACE), improves walking distance and health-related quality of life in patients with peripheral artery disease (PAD) associated with claudication.
Ramipril: a review of its use in preventing cardiovascular outcomes in high-risk patients. [2018]Ramipril is an oral, non-sulfhydryl ACE inhibitor thought to act in the renin-angiotensin-aldosterone system to decrease vasopressor activity, aldosterone secretion, and bradykinin degradation. Ramipril is generally well tolerated and effective in the treatment of patients aged > or =55 years at high risk for the development of cardiovascular (CV) events, in whom the risk of myocardial infarction (MI), stroke, and CV death can be significantly reduced. The risk of these CV outcomes may also be reduced with ramipril therapy in various subgroups; these include patients with diabetes mellitus, peripheral arterial disease (PAD) or renal insufficiency, and women. Thus, ramipril, in addition to lifestyle interventions, should be considered an important therapy in the prevention of CV outcomes in high-risk patients.
Spotlight on ramipril in the prevention of cardiovascular outcomes. [2018]Ramipril (Altace)Use of tradenames is for product identification purposes only and does not imply endorsement.), an angiotensin-converting enzyme (ACE) inhibitor, is a prodrug which is rapidly hydrolyzed after absorption to the active metabolite ramiprilat. Earlier trials have shown that ACE inhibitors, when given to patients with low ejection fractions, have reduced the relative risk of myocardial infarction (MI) and other ischemic events by 14-23%. Subsequently, the double-blind, randomized, placebo-controlled, multicenter Heart Outcomes Prevention Evaluation (HOPE) study has shown that, in patients who are not known to have low ejection fraction or heart failure but are at increased risk for developing cardiovascular events, ramipril reduced the incidence of stroke, MI and death due to cardiovascular disease. Results from the HOPE study, in which 9297 patients were randomized to receive either ramipril 10 mg/day or placebo for a mean of 4.5 years, indicate that ramipril reduced the relative risk of the composite outcome of MI, stroke and cardiovascular death by 22%. The incidence of the composite outcome was significantly lower in the ramipril group than in the placebo group (14.0% vs 17.8%). Patients who received ramipril, compared with placebo recipients, had a significantly decreased incidence of stroke, MI or death due to cardiovascular disease (3.4% vs 4.9%, 9.9% vs 12.3% and 6.1% vs 8.1%, respectively). The relative risk of death from any cause was reduced among patients who received ramipril. In addition, treatment with ramipril reduced as the incidence of revascularization procedures, and, among patients with diabetes mellitus, ramipril reduced the incidence of complications related to diabetes mellitus, including the development of overt nephropathy. Moreover, in patients without a previous diagnosis of diabetes mellitus, ramipril, compared with placebo, significantly reduced the development of diabetes mellitus. Furthermore, compared with patients receiving placebo, patients receiving ramipril had a reduced rate of progression of carotid artery wall thickness.
Effect of ramipril on renal function in patients with intermittent claudication. [2021]The Heart Outcomes Prevention Study (HOPE) demonstrated that ramipril resulted in a blood-pressure-independent 25% reduction in cardiovascular events in patients with peripheral arterial disease (PAD). Despite this, general practitioners and vascular surgeons remain reluctant to prescribe ACE inhibitors in this group of patients because of concerns about renal artery stenosis (RAS). We aimed to define the effect of ramipril on renal function in patients with intermittent claudication (IC).
Comparison of ramipril and enalapril in patients with essential hypertension. [2013]To compare the clinical safety and efficacy of ramipril, a new long-acting nonsulfhydryl inhibitor of angiotensin-converting enzyme (ACE), with enalapril.
Ramipril. An updated review of its therapeutic use in essential hypertension and heart failure. [2018]Ramipril is a second generation angiotensin converting enzyme (ACE) inhibitor. Like enalapril, it is a prodrug and is hydrolysed in vivo to release the active metabolite, ramiprilat, which has a long elimination half-life, permitting once-daily administration. The antihypertensive efficacy of ramipril has been confirmed in large-scale noncomparative studies conducted in general practice as well as in more rigorously controlled clinical trials. In the former, approximately 85% of patients with mild to moderate essential hypertension have responded successfully to treatment with ramipril 2.5 or 5 mg/day, while comparative trials indicate that the antihypertensive efficacy of the drug is equivalent to that of other established ACE inhibitors and the beta-adrenoceptor antagonist atenolol. As expected, the response rate to ramipril monotherapy is lower in patients with severe hypertension (around 40%), although the blood pressure lowering effect can be enhanced with the addition of a diuretic such as hydrochlorothiazide or piretanide. The antihypertensive efficacy of ramipril is maintained in patients with diabetes mellitus and preliminary data indicate that the drug has the beneficial effect of decreasing urinary albumin excretion in diabetic patients with nephropathy. Ramipril is superior to atenolol in causing regression of left ventricular hypertrophy, although the clinical significance of this effect per se remains to be established. The large-scale Acute Infarction Ramipril Efficacy (AIRE) study demonstrated that ramipril 5 or 10 mg/day significantly decreased the risk of all-cause mortality by 27% in patients with clinical evidence of heart failure after acute myocardial infarction, even if transient. The beneficial effect of ramipril was apparent by 30 days of treatment and appeared to be greatest in patients with more severe ventricular damage after infarction. Ramipril is well tolerated in general practice, with 5% or fewer patients discontinuing therapy because of drug intolerance. The data available suggest that ramipril shares a similar tolerability profile to that of other established ACE inhibitors. Thus, clinical data confirm ramipril as a useful alternative ACE inhibitor for the treatment of patients with mild to moderate hypertension, and indicate a beneficial effect of the drug in patients with clinical evidence of heart failure after acute myocardial infarction. It is also reasonable to assume that ramipril will be of value in the treatment of patients with more established heart failure or asymptomatic left ventricular dysfunction.
Ramipril. [2013]Ramipril is a long-acting, lipophylic angiotensin converting enzyme inhibitor, its principle action is to inhibit the conversion of angiotensin I to the active angiotensin II. Ramipril is indicated in the treatment of hypertension, congestive cardiac failure (including that following acute myocardial infarction), nephropathy (with and without diabetes mellitus) and now, following the findings of the HOPE study, in the prevention of cardiovascular events (including myocardial infarction) in high risk individuals. This article concentrates on reviewing the evidence supporting ramipril's use in these indications.