None listed
Conditions
Brief summary
Nitrates and Hydralazine are well known drugs being used in management of angina and hypertension. They have been tried in patients with heart failure who can not use Angiotensin Converting Enzyme (ACE) inhibitors and in African American population of USA on the top of ACE inhibitors, but have not been tested in addition to ACE inhibitors in Australian population. The purpose of this research study is to evaluate the benefit of optimising medical treatment in symptomatic patients with heart failure by addition of Nitrate and Hydralazine. This will hopefully translate into decrease of the symptoms of heart failure, increase in subjects exercise capacity and improvement of their quality of life.
Interventions
Randomised, Double Blind, Placebo Controlled, Crossover Design, Single Center Pilot Study.
Target Population: symptomatic adult patients with evidence of significant systolic left ventricle dysfunction (with Left Ventricle Ejection Fraction<40%) on maximal medical treatment.
Intervention: use of organic nitrates(isosorbide dinitrate) and hydralazine with placebo (tablets) as a comparator
Dose 40mg three times daily (Isosorbide) and 50mg three times daily (Hydralazine) for total of 12 months wi
Randomised, Double Blind, Placebo Controlled, Crossover Design, Single Center Pilot Study. Target Population: symptomatic adult patients with evidence of significant systolic left ventricle dysfunction (with Left Ventricle Ejection Fraction<40%) on maximal medical treatment. Intervention: use of organic nitrates(isosorbide dinitrate) and hydralazine with placebo (tablets) as a comparator Dose 40mg three times daily (Isosorbide) and 50mg three times daily (Hydralazine) for total of 12 months with 1 month washout. Crossover will be performed at 6 months (each arm will receive 6 months of study medications and 6 months of placebo ) Total number of visits 13. Informed consent will be obtained in the eligible subjects at the initial Visit 1. Visit 2, 3 and 4 will be scheduled in two weekly intervals. Subsequent visits will be at 2 monthly intervals (Visits 5, 6 and 7). A wash-out period will follow and will last 4 weeks. Subsequently crossover between treatment arms will be performed at Visit 8. Visit 9 and 10 follow every 2 weeks. Visits 11,12 and 13 planned at 2 monthly intervals.
Sponsors
Alphapharm
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
2.Chronic heart failure class II, III or IV New York Heart Association for > 3 months3. Left Ventricle Ejection Fraction <=40% (within 3 months of entry to the study)4. Stable medical therapy >3 months (including Beta Blocker, Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker and Spironolactone or Eplerenone if applicable. This inclusion criteria excludes Frusemide because Frusemide dosage may vary daily depending on medical advice.)5. Women of childbearing potential must be willing to use effective contraceptives to prevent pregnancy during the course of the study.6. Women of child-bearing potential must have a negative pregnancy before randomisation.
Exclusion criteria
1. Cardiogenic shock 2. Unstable coronary syndrome within 3/123. Recent myocardial infarction (3/12)4. Severe aortic stenosis5. Severe symptomatic coronary artery disease6. Restrictive cardiomyopathy, constrictive pericarditis7. Hypotension (mean Blood Pressure <80mmHg)8. Significant renal impairment with creatinine >200 mcmol/l 9. Unable to provide consent, comply with follow-up visits and/or respond to the questionnaire10. Currently involved in or has been involved in another clinical trial using an investigational drug or device in the previous 30 days.
Outcome results
None listed