None listed
Conditions
Brief summary
Invasively measure haemodynamics (right heart catheterization and arterial line) at rest and during exercise (Ex 1) in patients with presumed HFPEF and to repeat these measures after random allocation to milrinone or placebo
Interventions
Following initial rest and exercise evaluation during Right Heart Catheterization (RHC), patients will be randomly allocated (by envelope) to receive either a standard loading dose of Intravenous (IV) milrinone (50mcg/kg over 10 mins) or placebo. This will be a single dose.
Rest and exercise haemodynamic and echocardiographic studies (as above) will be repeated after a further 10 minutes following the administration of the IV Milrinone.
Following baseline measures, subjects will supine perform
Following initial rest and exercise evaluation during Right Heart Catheterization (RHC), patients will be randomly allocated (by envelope) to receive either a standard loading dose of Intravenous (IV) milrinone (50mcg/kg over 10 mins) or placebo. This will be a single dose. Rest and exercise haemodynamic and echocardiographic studies (as above) will be repeated after a further 10 minutes following the administration of the IV Milrinone. Following baseline measures, subjects will supine perform symptom-limited supine cycling at incremental levels of 0.3, 0.6, 1.0 and 1.5Watt/kg each for 3 minutes (exercise will not be performed if the resting RHC unexpectedly demonstrates severe pulmonary hypertension PA systolic>60mmHg). The test will be stopped when the patient experiences limiting dyspnoea or other limiting symptoms.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults greater than or equal to 18 years of age, AND Symptoms of HF (NYHA II-III) AND Normal ejection fraction (LVEF equal to and more than 45%) with evidence of diastolic dysfunction as prescribed by ESC Working Group 15 (resting PCWP more than 12; E/e’ more than 15 or Eand e prime more than 8 and and NT-BNP more than 220)
Exclusion criteria
Other cause for dyspnoea including moderate or severe valvular HD and pulmonary hypertension with PVR more than 4 Wood Units Body mass index (BMI) more than 35 kg/m2 History of stress-induced syncope or ventricular tachycardia during exercise Unstable coronary artery disease Symptoms and signs of congestive heart failure at rest (NYHA IV) Unable to perform exercise test
Outcome results
None listed