Status:
COMPLETED
Spironolactone Therapy in Chronic Stable Right HF Trial
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Chronic Right-Sided Heart Failure
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart ...
Detailed Description
This study is a phase 4, single center, randomized, double blind, placebo-controlled trial evaluating the safety, tolerability and mechanistic effects of spironolactone, an aldosterone antagonist, on ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03344159
Start Date
April 1 2018
End Date
May 1 2024
Last Update
July 1 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7