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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Ventricular Wall Stress
Timeframe: Baseline and 12 weeks
Trial details
NCT IDNCT03344159
SponsorOttawa Heart Institute Research Corporation