DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)

Information source: Hamilton Health Sciences Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Disease

Intervention: Atenolol (Drug); Telmisartan (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hamilton Health Sciences Corporation

Official(s) and/or principal investigator(s):
Judith Therrien, MD, Principal Investigator, Affiliation: MdGill University

Overall contact:
Tara McCready, PhD, Phone: 905-527-4322, Ext: 40439, Email: tara.mccready@phri.ca

Summary

The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening (dilatation) of the aorta from its baseline size.

Clinical Details

Official title: Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Change from baseline in ascending aorta size, as evaluated by MRI

Secondary outcome: Rate of change in ascending aorta size evaluated by transthoracic echocardiography (TEE).

Detailed description: Bicuspid aortic valve (BAV) is the most common congenital heart disease lesion with an estimated 280 000 to 560 000 people affected in the Canada. Dilatation of the ascending aorta is a common feature in patients with BAV and is a result of inherent vascular abnormalities with superimposed effects of age and acquired cardiovascular risk factors. Severe aortic dilatation (> 50mm) leads to aortic dissection and premature death. Histopathological studies of the aortas in patients with BAVs report similar findings to that of patients with Marfan syndrome. Beta Blocker (BB) therapy and more recently, Angiotensin Receptor Blocker (ARB) therapy, have been shown to decrease to rate of aortic dilatation and be of benefit to patients with Marfan syndrome. There is no such data however in patients with BAV and aortopathy. Within the context of a randomized clinical trial, the investigators proposed to test the hypothesis that BB or ARB will reduce the rate of progressive aortic dilatation in adults with BAVs and ascending aortopathy as compared to placebo. Design: Multicentre, randomized, double-blind, placebo-controlled, trial of adult patients with bicuspid aortic valve aortopathy. Patients who are eligible to take either study medication will be randomly allocated to participate in either the BB (atenolol) vs. placebo arm, or the ARB (telmisartan) vs. placebo arm. Patients who are ineligible for the BB arm will be assigned to the ARB vs. placebo arm and patients who are ineligible for the ARB arm will be assigned to the BB vs. placebo arm. Within each arm, all participants will be randomized to take either placebo or active medication. The atenolol arm will be up-titrated to100mg/day and the telmisartan arm will be up-titrated to 80 mg/day, or to the maximum tolerated dose.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age => 18 years

- Men and women with BAV and ascending aorta measuring > 37mm.

- Written informed consent

General Study Exclusion Criteria 1. History of cardiac diseases, such as

- Symptomatic aortic stenosis or aortic regurgitation referred for surgical

intervention or asymptomatic severe aortic stenosis or regurgitation based on current guidelines

- Uncontrolled heart failure, right ventricular failure due to pulmonary

hypertension

- Cardiogenic shock

2. Systolic blood pressure < 100 mmHg 3. History of drug sensitivity, contraindication or adverse reaction to both BB and ARB. Participants who are able to tolerate only a BB will be allocated to the BB vs. placebo arm, and participants who are able to tolerate only an ARB will be allocated to the ARB vs. placebo arm, assuming no other exclusion criteria are met. 4. Ascending aorta measuring ≥ 50mm, requiring prophylactic ascending aorta surgery 5. Unable to provide informed consent 6. Need for both BB and ARB for treatment of concomitant medical conditions for which there are no other alternatives. Participants who are taking an ARB which cannot be discontinued will be allocated to the BB arm, and participants who are taking a BB which cannot be discontinued will be allocated to the ARB arm, if no other exclusion criteria are met. 7. Prior surgery on ascending aorta or aortic root (balloon valvuloplasty, aortic valvotomy or post coarctation surgery are acceptable) 8. Women who are pregnant at screening visit 9. Contraindication to MRI (claustrophobia, pacemaker, metallic clip in eye or brain) 10. History of any illness which limits the participants' ability to complete the study Additional Exclusion Criteria for BB arm only 1. Heart rate <60 bpm 2. Heart block (1st, 2nd and 3rd degree AV block on ECG), or sick sinus syndrome 3. Asthma of sufficient severity to represent a contraindication to BB use in the judgment of the patient's physician 4. History of severe peripheral artery disorders 5. History of pheochromocytoma without the use of alpha-adrenergic blockers 6. History of metabolic acidosis Additional Exclusion Criteria for ARB arm only 1. Women who are pregnant, lactating or who intend to become pregnant during the course of the study 2. Women who are of childbearing age and are not on reliable, accepted form of birth control 3. Hyperkalemia [serum potassium > 5. 5 mmol/L] or renal dysfunction [GFR<45% measured by MDRD) 4. Patients being treated with an ACE Inhibitor that cannot be discontinued. (These patients may be randomized in the BB arm if no exclusion criteria are met.) 5. History of bilateral renal artery stenosis or unilateral renal artery stenosis to a solitary kidney 6. History of hepatic insufficiency and hepato-biliary obstruction 7. History of fructose intolerance

Locations and Contacts

Tara McCready, PhD, Phone: 905-527-4322, Ext: 40439, Email: tara.mccready@phri.ca

Mazankowski Alberta Heart Institute, Edmonton, Alberta T6G 2B7, Canada; Recruiting
Isabelle VonderMuhll, Principal Investigator

University of British Columbia, Vancouver, British Columbia V6Z 1Y6, Canada; Recruiting
Jasmine Grewal, Principal Investigator

St. Boniface Hospital, Winnipeg, Manitoba, Canada; Recruiting
James Tam, Principal Investigator

Hamilton Health Sciences-General, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Omid Salehian, Principal Investigator

Population Health Research Institute - Coordinating Centre, Hamilton, Ontario L8L2X2, Canada; Active, not recruiting

London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting
Samuel Siu, Principal Investigator

St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Michael Kutryk, MD, Principal Investigator

Toronto General Hospital/University of Toronto, Toronto, Ontario, Canada; Recruiting
Candice Silversides, Principal Investigator

Cité de la Santé de Laval, Laval, Quebec H7M 3L9, Canada; Recruiting
Laurence Descarries, MD, Principal Investigator

Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada; Recruiting
Judith Therrien, Principal Investigator

McGill University Health Centre, Montreal, Quebec H3A 1A1, Canada; Recruiting
Judith Therrien, Principal Investigator

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting
Hoa Do, MD, Principal Investigator

Regina General Hospital, Regina, Saskatchewan S4P 0W5, Canada; Recruiting
Payam Dehghani, MD, Principal Investigator

Additional Information

Starting date: June 2011
Last updated: July 6, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017