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Aldosterone Receptor Antagonist

Spironolactone for Pulmonary 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
Current NYHA II-IV
Male or female ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights

STAR-HF 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 Hypertension
  • Right Ventricular Cardiomyopathy
  • Pulmonary Arterial Hypertension
  • Right-Sided Heart Failure

STAR-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STAR-HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Ventricular Wall Stress
Secondary outcome measures
Change in Biomarkers of Fibrosis
Change in Cardiac Autonomic Nervous System Function
Change in Cardiac Sympathetic Nervous System Activity
+5 more
Other outcome measures
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%
Hyperkalemia
5%
Diabetes related
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

STAR-HF 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
Spironolactone
2005
Completed Phase 4
~7340
PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82
2018
Completed Phase 4
~20
Cardiac MRI (Gadolinium enhanced)
2018
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,421 Total Patients Enrolled
Lisa Mielniczuk, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
1,390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Spironolactone for therapeutic use?

"The safety of Spironolactone, a medication that has already been approved by regulatory bodies, is given an estimation score of 3."

Answered by AI

Are there any past studies that have assessed the efficacy of Spironolactone?

"Currently, there are 28 active trials examining the use of spironolactone. Of those clinical studies, 7 have been approved for Phase 3 testing. These research efforts are mainly based in Boston, Massachusetts but other medical centres across 293 locations also offer access to this treatment."

Answered by AI

What medical conditions has Spironolactone been demonstrated to alleviate?

"Spironolactone is usually prescribed to treat primary hyperaldosteronism, yet its application extends beyond this illness. It has also been proven beneficial in the treatment of cirrhosis, acne management, and other therapeutic procedures."

Answered by AI

How many participants are signed up for this medical investigation?

"Yes, according to the information available on clinicaltrials.gov this medical trial is actively recruiting patients. It was initially posted on April 1st 2018 and last updated November 19th 2021 with a goal of enrolling 30 participants from one site."

Answered by AI

Are any new participants being accepted for this trial?

"As per clinicaltrials.gov, this research is currently recruiting patients having been published on April 1st 2018 with changes to the study occurring as recently as November 19th 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Spironolactone Therapy in Chronic Stable Right HF Trial
Lisa Mielniczuk 2018. "Spironolactone Therapy in Chronic Stable Right HF Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03344159.
~2 spots leftby Apr 2025
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