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Spironolactone Therapy in Chronic Stable Right HF Trial

Sponsored by Ottawa Heart Institute Research Corporation

About this trial

Last updated 3 years ago

Study ID

20170694

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Yes

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.