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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Ottawa Heart Institute
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.