Spironolactone Therapy in Chronic Stable Right HF Trial (NCT03344159) | Clinical Trial Compass
CompletedPhase 4
Spironolactone Therapy in Chronic Stable Right HF Trial
Canada15 participantsStarted 2018-04-01
Plain-language 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 function and remodeling in patients with chronic right heart failure.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change in Ventricular Wall Stress
Timeframe: Baseline and 12 weeks
Trial details
NCT IDNCT03344159
SponsorOttawa Heart Institute Research Corporation