Spironolactone Therapy in Chronic Stable Right HF Trial (STAR-HF)
Chronic Right-Sided Heart Failure, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Primary, 2
About this trial
This is an interventional treatment trial for Chronic Right-Sided Heart Failure focused on measuring Mineralocorticoid receptor antagonist, Brain natriuretic peptide (BNP), Sympathetic Nervous System, Positron Emissions Tomography
Eligibility Criteria
Inclusion Criteria:
- Provide a personally signed and dated inform consent form.
- Male or female ≥ 18 years.
- Able to comply with all study procedures.
History of right heart failure (RHF) secondary to either:
i) WHO, group 1 pulmonary arterial hypertension PAH OR ii) WHO group II PH with normal LV systolic function OR iii) WHO group III or IV PH OR iv) primary RV cardiomyopathy.
- Current NYHA II-IV
RV dysfunction as measured by 2D echocardiogram:
i)defined as a tricuspid annular plane systolic excursion (TAPSE) <16 mm ii) and /or a two dimensional fractional area change <35% on screening echo plus
- NT-proBNP>400 pg/ml
- Chronic use of diuretics
- Clinical stability: defined as no need for increased diuretics, hospitalization or emergency room visit 3 months prior to enrollment
Exclusion Criteria:
- Patients on chronic MRA therapy or other potassium sparing diuretics.
- Baseline serum potassium>5 ummol/l.
- Estimated glomerular filtration rate <30 ml/min.
- LV ejection fraction <45%,
- Moderate or severe LV diastolic function,
- Moderate or severe aortic or valvular disease.
- Patients requiring augmentation of diuretics or otherwise not meeting definition for clinical stability.
- Severe Liver Failure (Child-Pugh Class C)
- Claustrophobia or inability lie still in a supine position
- Patients with contraindications to either PET or CMR imaging
- Pregnancy or lactation.
- Unable to provide consent and comply with follow up visits.
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Spironolactone
Placebo
Participants with chronic right-sided heart failure will receive spironolactone 12.5mg daily up to a maximum dose of 50 mg daily for a total duration of 12 weeks.
Participants with chronic right-sided heart failure will receive placebo daily for a total duration of 12 weeks.