MedTrace Logo

Spironolactone Therapy in Chronic Stable Right HF Trial

NCT03344159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Chronic Right-Sided Heart Failure
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension, Primary, 2
  • Pulmonary Hypertension, Primary, 3
  • Pulmonary Hypertension, Primary, 4
  • Cardiomyopathy Right Ventricular

Interventions

DRUG

Spironolactone

Spironolactone 12.5mg daily up to a maximum dose of 50 mg daily if tolerated for a total duration of 12 weeks.

DRUG

Placebo

Placebo daily for a total of duration of 12 weeks

RADIATION

PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82

At baseline and 12 weeks, all participants will undergo rest perfusion PET imaging according to standard protocols with either 82-Rb or N-13 NH3, followed by C-11 HED PET.

DIAGNOSTIC_TEST

Cardiac MRI (Gadolinium enhanced)

At baseline and 12 weeks all participants will undergo cMR to assess RV function and structure. We will acquire precontrast T2 and native T1 maps, and post gadolinium T1 maps.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2022-08-30
Completion
2024-05-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344159 on ClinicalTrials.gov