Clinical Trial: Withdrawal of Medication in Recovered DCM

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Withdrawal of Beta- Blockers and ACE Inhibitors After Left Ventricular Systolic Function Recovery in Patient With Dilated Cardiomyopathy: A Randomized Control Trial.

Brief Summary: Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy.

Detailed Summary:

Importance of the study:

There is a growing population of patients with dilated cardiomyopathy (DCM) who had recovered left ventricular (LV) systolic function on medical therapy. Recent studies have shown a favorable clinical course in patients with DCM1-4. The heart failure (HF) guidelines states that discontinuation of medical therapy in this group of patients may be considered based on expert opinion. The safety of withdrawal of medical therapy needs further studies.

Hypothesis:

In Patients with dilated cardiomyopathy (DCM) who had recovery of the LV systolic function to a normal EF >50%, medical therapy withdrawal is attainable without Clinical deterioration or recurrence of LV systolic dysfunction.

Objective

  1. To study the withdrawal of guideline directed medical therapy, specifically beta-blockers and ACE/ARB, in patients with DCM after recovery of LV EF.
  2. Correlate the sustained recovery in LVEF after medication discontinuation with specific genetic markers of recovery.

Method:

Study design:

It is a multi-center, non-blinded, randomized Control trial (pilot) comparing withdrawal of medical therapy in patients with recovered LVEF (recEF) compared to patients continuing medical therapy. Therapeutic changes will occur in a 2:1 randomization at the Royal Victoria Hospital, the Montreal General Hospital and the Jewish General Hospital. Patient would be recruited from a Heart Function Clinic or the echocardiography lab.

Same as current

Current Secondary Outcome:

  • Number of patients that maintain LVEF > or = 50% [ Time Frame: 1 year ]
  • Average BNP level compared to baseline BNP level [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: McGill University

Dates:
Date Received: April 29, 2016
Date Started: February 2016
Date Completion: July 2018
Last Updated: May 11, 2016
Last Verified: May 2016