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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

Assessing the acute haemodynamic effects of hydralazine and nitrates, singly and in combination, in patients with chronic heart failure using novel non-invasive sensor technologies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04764631
Enrollment
26
Registered
2013-05-08
Start date
2013-04-01
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure Circulatory System Heart failure

Interventions

Randomisation will be by blocks using an unequal block size. Control group ? 10 patients with hypertension or coronary artery disease but not heart failure. The control group does not

Sponsors

Hull and East Yorkshire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
No 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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026