Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease

Hypertension Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Usual Care With a Multifactorial Intensified Intervention on Cardiovascular Risk Factors in Subjects With Arterial Peripheral Disease With and Without Diabetes. The Taulí Intervention Program (TIP).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00144937
• Other study ID #: 2003020
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: September 1, 2005
• Start date: March 2003
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: Hospital de Sabadell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation to the habitual care

Description:

Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smoking) could be beneficial in reducing their cardiovascular risk. However, usual care of these subjects (mainly at primary care) is not associated with an optimal control of such cardiovascular risk factors. We hypothesise that an intensive multifactorial treatment in a Cardiovascular Risk Unit could improve control of these cardiovascular risk factors. To test this hypothesis we perform a controlled, randomized, open, parallel trial. Subjects are recruited at the Vascular Surgery Unit and are randomised into two groups: 1. usual care (control group); 2. intensive care (intervention group). Randomization is stratified for the presence/absence of diabetes mellitus and with the use of sealed envelopes. Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo intensive multifactorial intervention. This intervention involves strict treatment goals (LDL-cholesterol < 100 mg/dl, blood pressure < 130/80, HbA1c < 7 %, no smoking) to be achieved through behavior modification (diet, physical activity, smoking cessation) and a stepwise introduction of pharmacologic therapy for hypercholesterolemia, hypertension and diabetes. This multifactorial intervention is overseen by a multidisciplinary team (endocrinologist, nurse, and dietitian) at the Hospital of Sabadell (Corporación Parc Taulí). The treatment goals are the same for the usual care group and general practitioners caring patients included in this study are informed of these strict treatment goals. Patients in the intensive-therapy receive 6 scheduled individual consultations in one year (baseline and 2,4, 6 and 9 months after their inclusion).Primary and secondary outcomes are evaluated at 12 months after their inclusion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Arm-ankle index < 0.85 and > 0.40 in at least one leg

Exclusion Criteria:

• Advanced peripheral arterial disease (arm-ankle index < 0.40 or amputation)

• Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)

• Heart failure (NYHA III or IV)

• End-stage renal disease

• Atrial fibrillation

• Active peptic ulcer disease

• Blood coagulation disorders

• Platelets disorders

• Cancer

• History of rhabdomyolysis

• Treatment with immunosuppressant agents (e.g. cyclosporine, glucocorticoids)

• Excessive intake of alcohol (> 280 gr/week)

• Institutionalized patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypercholesterolemia
• Hypertension
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Smoking

Intervention

Drug:
• Stepwise therapy for dyslipidemia, hypertension and diabetes

Behavioral:
• Dietary recommendations

• Increase in physical activity

• Smoking cessation

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Sabadell	Bristol-Myers Squibb

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
Secondary	Decrease in basal glycaemia and HbA1c(only subjects with diabetes)
Secondary	Lowering of serum triglycerides and total cholesterol.
Secondary	Increase in serum HDL cholesterol
Secondary	Improvement in cardiovascular risk (Framingham Score and UKPDS engine)
Secondary	Weight reduction
Secondary	Increase in physical activity
Secondary	Changes in dietary intake
Secondary	Smoking cessation
Secondary	Improvement in health-related quality of life (SF-36)
Secondary	Improvement of intermittent claudication
Secondary	Improvement of arm-ankle index
Secondary	Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease
Secondary	Changes in serum concentrations of hepatic enzymes
Secondary	Changes in use of statins and fibrates
Secondary	Changes in use of antihypertensive drugs and hypoglycemic agents
Secondary	Cardiovascular events
Secondary	All the above-mentioned primary and secondary outcomes will be evaluated at 12 months