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Aldosterone Receptor Antagonist

Spironolactone for Pulmonary Arterial Hypertension (STAR-HF Trial)

Phase 4
Waitlist Available
Led By Lisa Mielniczuk, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will study whether spironolactone is safe and effective in reducing sympathetic nervous system activity and right heart function in patients with chronic right heart failure.

Eligible Conditions
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Right Ventricular Cardiomyopathy
  • Right-Sided Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Ventricular Wall Stress
Secondary study objectives
Change in Biomarkers of Fibrosis
Change in Cardiac Autonomic Nervous System Function
Change in Cardiac Sympathetic Nervous System Activity
+5 more
Other study objectives
Change in NYHA function class
Change in Right heart failure Severity
Aldosterone
+2 more

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Infection
5%
Hyperkalemia
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpironolactoneExperimental Treatment3 Interventions
Participants with chronic right-sided heart failure will receive spironolactone 12.5mg daily up to a maximum dose of 50 mg daily for a total duration of 12 weeks.
Group II: PlaceboPlacebo Group3 Interventions
Participants with chronic right-sided heart failure will receive placebo daily for a total duration of 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac MRI (Gadolinium enhanced)
2018
Completed Phase 4
~20
Spironolactone
2005
Completed Phase 4
~14580
PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82
2018
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
194 Previous Clinical Trials
92,997 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
20 Patients Enrolled for Pulmonary Arterial Hypertension
Lisa Mielniczuk, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
1,390 Total Patients Enrolled
~2 spots leftby Nov 2025
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