Status:

WITHDRAWN

Study of High Dosage of Losartan in Comparison to Low Dose of Losartan in Heart Failure Patients

Lead Sponsor:

Baker Heart and Diabetes Institute

Conditions:

Heart Failure

Eligibility:

All Genders

21-75 years

Phase:

PHASE4

Brief Summary

The sympathetic nervous system, a part of the nervous system that stimulates the heart via release of substances, noradrenaline and adrenaline (combined called catecholamines), becomes activated in pe...

Eligibility Criteria

Inclusion

  • Males and females age between 21 and 75 years
  • Diagnosis of mild to moderate congestive heart failure
  • Coronary angiography identifying coronary artery disease as the likely cause of congestive heart failure
  • Left Ventricular (LV) ejection fraction between 20 to 40 percent on echocardiography or RNA
  • Sinus rhythm

Exclusion

  • Insulin-dependent diabetes mellitus
  • Hypertension (higher than 140/90 mmHg at rest)
  • Use of sympatholytic agents such as clonidine, methyldopa, reserpine
  • Significant non-cardiac disease, possibly affecting cardiovascular regulation
  • Autonomic neuropathy of any cause
  • Leg injuries with nerve damage
  • Poor bladder control
  • Recent history of alcoholism, drug abuse, significant psychiatric disorders
  • Known adverse events to AT1-receptor blockers
  • Unlikely to tolerate being off digoxin and off blockers of the RAS for a short period
  • Ischemic event within past 3 months
  • Serum creatinine higher than 200 mmol/L
  • Patients taking digoxin for atrial fibrillation
  • Patients who require treatment with aldactone
  • Patients with more than mild stable angina while on beta-blockers and/or calcium antagonists
  • Patients on coumadin

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02238457

Last Update

November 2 2018

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