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Trial registered on ANZCTR


Registration number
ACTRN12608000030370
Ethics application status
Not yet submitted
Date submitted
15/01/2008
Date registered
18/01/2008
Date last updated
18/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Isosorbide dinitrate and hydralazine in symptomatic systolic heart failure.
Scientific title
Effect of Isosorbide dinitrate(ISDN) and hydralazine(HYD) on left heart filling pressures in symptomatic systolic heart failure.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 2723 0
Condition category
Condition code
Cardiovascular 2844 2844 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2461 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3729 0
To determine if the use of isosorbide dinitrate(ISDN) and hydrallazine(HYD) can reduce pulmonary artery pressure(PAP) and left atrial pressure in patients with symptomatic systolic heart failure who have evidence of pulmonary hypertension(PH) and/or elevated estimated left atrial pressure as measured on right heart study.
Timepoint [1] 3729 0
4 weeks
Secondary outcome [1] 6294 0
Assessment of functional/haemodynamic improvements with treatment as assessed by Transthoracic Thoracic Echocardiography criteria
Timepoint [1] 6294 0
4 weeks
Secondary outcome [2] 6295 0
Assessment of functional/haemodynamic improvements with treatment as assessed by change in BNP( B type natriuretic peptide) levels
Timepoint [2] 6295 0
4 weeks
Secondary outcome [3] 6296 0
Assessment of functional/haemodynamic improvements with treatment as assessed by change in Kansas city questionaire score.
Timepoint [3] 6296 0
4 weeks
Secondary outcome [4] 6297 0
Assessment of functional/haemodynamic improvements with treatment as assessed by 6 minute walk distance
Timepoint [4] 6297 0
4 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 555 0
3050

Funding & Sponsors
Funding source category [1] 2972 0
Hospital
Name [1] 2972 0
The Royal Melbourne Hospital
Address [1] 2972 0
Grattan Street, Parkville. 3050
Country [1] 2972 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Grattan Street, Parkville. 3050
Country
Australia
Secondary sponsor category [1] 2681 0
None
Name [1] 2681 0
Address [1] 2681 0
Country [1] 2681 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4929 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 4929 0
The Royal Melbourne Hospital
Grattan Street, Parkville. 3050
Ethics committee country [1] 4929 0
Australia
Date submitted for ethics approval [1] 4929 0
21/01/2008
Approval date [1] 4929 0
Ethics approval number [1] 4929 0
Ethics committee name [2] 4930 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 4930 0
The Royal Melbourne Hospital
Grattan Street, Parkville. 3050
Ethics committee country [2] 4930 0
Australia
Date submitted for ethics approval [2] 4930 0
21/01/2008
Approval date [2] 4930 0
Ethics approval number [2] 4930 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28304 0
Address 28304 0
Country 28304 0
Phone 28304 0
Fax 28304 0
Email 28304 0
Contact person for public queries
Name 11461 0
Ken Lu
Address 11461 0
Department of Cardiology
The Royal Melbourne Hospital
Grattan Street, Parkville 3050
Country 11461 0
Australia
Phone 11461 0
(03)93427000
Fax 11461 0
Email 11461 0
Ken.Lu@mh.org.au
Contact person for scientific queries
Name 2389 0
Anuradha Aggarwal
Address 2389 0
Department of Cardiology
The Royal Melbourne Hospital
Grattan Street, Parkville 3050
Country 2389 0
Australia
Phone 2389 0
(03)93427133
Fax 2389 0
Email 2389 0
Anuradha.Aggarwal@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results