NCT03344159CompletedPhase 4
Spironolactone Therapy in Chronic Stable Right HF Trial
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 28 Sept 2017
- Start date
- 1 Apr 2018
- Primary completion date
- 30 Aug 2022
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- NCT number
- NCT03344159
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 15
- From 1 Apr 2018 to the primary completion date, 30 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Moderate or severe aortic or valvular disease.
- Severe Liver Failure (Child-Pugh Class C)
Lab values
- Patients on chronic MRA therapy or other potassium sparing diuretics.
- Baseline serum potassium\>5 ummol/l.
- LV ejection fraction \<45%,
Other
- Estimated glomerular filtration rate \<30 ml/min.
- Moderate or severe LV diastolic function,
- Patients requiring augmentation of diuretics or otherwise not meeting definition for clinical stability.
- 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.
Who the study is looking for
- 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:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.