The acute effects of glyceryl trinitrate (GTN) on exercise capacity in patients who have an implantable cardiac pump (LVAD)

Phase 2

Recruiting

Conditions: Heart failure
Cardiovascular - Other cardiovascular diseases

Registration Number: ACTRN12623000116628

Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

•Willingness to give written informed consent and willingness to participate to and comply with the study.
•Age greater or equal to 18
•Clinically stable: no new additional disease-modifying drug (angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, sacubitril, beta-blocker), no change in disease-modifying drug dosage more than 50% (excluded: diuretics), no recent (previous 3 months) admission to the hospital with decompensated heart failure.
•Ambulatory.
•>8 weeks after pump insertion.

Exclusion Criteria

•Active, uncontrolled infection.
•Exercise induced myocardial ischaemia or significant arrhythmias.
•Recent acute coronary syndrome (<6 weeks).
•Limiting musculoskeletal disorder.
•Poor exercise capacity on 6MWT
•Significant lung disease that is likely to limit exercise capacity
•Exercise induced asthma
•Regular sildenafil use.
•Hypotension (mean arterial pressure <65mmHg)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in peak VO2 between the cardiopulmonary tests with GTN and placebo, as assessed using a cardiometabolic cart<br>[ First CPET session and second CPET session (7-28 days apart)];Distance completed during 6 minute walk test, measured in a corridor with a known distance [ First 6 minute walk test and second 6 minute walk test (7-28 days apart).<br>These tests occur in parallel with the CPETs and no specific timeframe has been specified relative to the performance of the CPETs.]

Secondary Outcome Measures

Name	Time	Method
Difference in exercise duration during CPET, as measured by the integrated bicycle ergometer/computer software<br>[ First CPET session and second CPET session (7-28 days apart)];Difference in ventilatory efficiency (Ve/VCO2 slope), as assessed by the cardio metabolic cart during CPET<br>[ First CPET session and second CPET session (7-28 days apart)];Difference in fatigue levels as assessed by Borg Scale<br>[ First 6 minute walk test and second 6 minute walk test (7-28 days apart)]