None listed
Conditions
Brief summary
Isosorbide dinitrate and hydralazine have been shown in previous trials to be beneficial in heart failure patients. Previous haemodynamic based studies have been conducted with older forms of treatment of heart failure, and larger clinical studies have been largely focused on African Americans. The purpose of the study is to evaluate the effect of Isosorbide dinitrate and hydralazine on Pulmonary and left heart pressures in patients with symptomatic heart failure with documented pulmonary hypertension on comtemporary treatment. indirect assessemt of improvement will be evaluated with functional scores, and exercise distance. Patients meeting the study (inclusion and exclusion) criteria will be recruited via the cardiomyopathy service (outpatient)and inpatient ward at the Royal Melbourne Hopsital. Informed consent will be obtained. Screening phase of the study will include baseline investigations and the right heart study. Stabilisation phase takes place in next 2-4 weeks till stable doses of study medication achieved. Treatment phase will commence and parameters reassessed at end of study period.
Interventions
This is a prospective haemodynamic based study in patients with CHF and pulmonary hypertension and/or elevated estimated left atrial pressure who are already on stable and optimsed doses of traditional heart failure medications. This will be a single center study, with enrolment expected to occur over 6 months. Following infromed consent, there will be an initial screening phase, with the performance of a right heart study to document baseline haemodynamic data. All patients will be commenced
This is a prospective haemodynamic based study in patients with CHF and pulmonary hypertension and/or elevated estimated left atrial pressure who are already on stable and optimsed doses of traditional heart failure medications. This will be a single center study, with enrolment expected to occur over 6 months. Following infromed consent, there will be an initial screening phase, with the performance of a right heart study to document baseline haemodynamic data. All patients will be commenced on combination oral ISDN and HYD. Titration of the study medications will occur over the next 2-6 weeks beginning with 60mg and 37.5mg ISDN and HYD respectively, then aiming to reach ISDN dose 120mg and HYD dose 225mg daily respectively. A treatment phase will follow with regular review of the patients in clinic for progress and side effects of medications. At the end of the study period( 4 weeks), a repeat right heart study will be conducted to assess cardiac pressures.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
·>18 year old ·Non African background ·Heart failure as defined by Left ventricular ejection fraction ( measured on TTE)< 45%New York Heart Association(NYHA) functional class II-III for at least 3 months ·Pulmonary hypertension secondary to systolic heart failure ( Right Ventricular systolic pressure (RVSP) > 45mmHg on TTE) ·On optimized and stable doses of traditional neurohormonal heart failure medications, Ace inhibitor(ACEI), Beta blockers and spironolactone for at least one month ·Systolic blood pressure > 90mmHg
Exclusion criteria
·Recent diagnosis( < 3 months) Acute myodcardial infarction(AMI), Congestive cardiac failure(CCF), percutaneous coronary intervention(PCI) or cardiac surgery. ·Pregnancy ·Significant aortic or mitral stenosis ·Concurrent illnesses likely to shorten life.
Outcome results
None listed