Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

Heart Failure Clinical Trial

Official title:

The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02888561
• Other study ID #: 199826
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: August 30, 2016
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Left Ventricular Ejection Fraction <40%

2. Patients aged >18 years

3. Able to provide written consent

Exclusion Criteria:

1. Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects

2. Haemodynamic Instability

3. Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Dobutamine
Dobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.
• Nitrite
Nitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.

Locations

Country	Name	City	State
United Kingdom	British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Flow (average peak velocity)		During procedure.	No
Primary	left ventricular stroke work		during procedure	No
Secondary	rate pressure product		during procedure	No
Secondary	pressure volume area		during procedure	No
Secondary	coronary microvascular resistance		during procedure	No
Secondary	stroke volume		during procedure	No
Secondary	Distal tissue perfusion		during procedure	No
Secondary	Magnitude of forward compression wave		during procedure	No
Secondary	magnitude of backward expansion wave		during procedure	No