Isosorbide dinitrate and hydralazine in symptomatic systolic heart failure.

Phase 4

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12608000030370
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[4 weeks]

Secondary Outcome Measures

Name	Time	Method
Assessment of functional/haemodynamic improvements with treatment as assessed by Transthoracic Thoracic Echocardiography criteria[4 weeks];Assessment of functional/haemodynamic improvements with treatment as assessed by change in BNP( B type natriuretic peptide) levels[4 weeks];Assessment of functional/haemodynamic improvements with treatment as assessed by change in Kansas city questionaire score.[4 weeks];Assessment of functional/haemodynamic improvements with treatment as assessed by 6 minute walk distance[4 weeks]