The HeartCycle Nitrates Study - to assess the effectiveness of non-invasive devices in measuring responses to hydralazine with and without isosorbide mononitrate in heart failure patients
- Conditions
- Chronic heart failureCirculatory SystemHeart failure
- Registration Number
- ISRCTN04764631
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1. Male and female, 18 y.o. plus, legally able to provide written informed consent
2. Clinical diagnosis of Heart Failure
3. Objective evidence of cardiac dysfunction
3.1. NTproBNP >200ng/L and at least one of the following:
3.2. Left ventricular ejection fraction (=45%)
3.3. Left atrial dimension >40mm
4. Treated with at least 40mg/day of furosemide or 1mg/day of bumetanide
5. Receiving other guideline indicated therapy for heart failure
6. Patients should be in sinus rhythm. Atrial fibrillation may reduce accuracy of some signals
1. Patients with implanted pacemakers or defibrillators
2. Severe aortic or mitral valve disease
3. Breathlessness at rest or on minor exertion
4. Chest pain at rest or on mild or moderate exertion
5. Patients with unstable heart failure or 'brittle' diabetes
6. Patients who are known to be intolerant [including patients using Phosphodiesterase type 5 (PDEV) inhibitors] of nitrates or hydralazine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o single primary outcome. This is a pilot study to investigate the ability of novel noninvasive sensors to detect and track the acute haemodynamic effects of medication (hydralazine and/or hydralazine or combination) and a series of physiological manoueuvres.
- Secondary Outcome Measures
Name Time Method o secondary outcome measures