NCT01468571

Brief Summary

The purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. In addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

4 years

First QC Date

November 3, 2011

Last Update Submit

May 6, 2015

Conditions

Pulmonary Hypertension

Keywords

Potassium Sparing DiureticsRight-sided heart failureEdema

Outcome Measures

Primary Outcomes (1)

  • Change in biomarker levels in the spironolactone treated as compared to placebo treated group.

    50 participants will be enrolled in a 16-week study, and each subject will receive placebo or active drug in a random order. At the end of week 8, treatment arm for each subject will be blindly switched. Biomarker levels will be drawn 3 times (baseline, week 8, and week 16) during the study period for each subject.

    16 week

Secondary Outcomes (3)

  • Number of adverse events in patients treated with spironolactone as compared to placebo.

    16 week

  • Change in six-minute walk distance from baseline to week 8 and week 16.

    16 week

  • Composite end-point

    16 week

Study Arms (2)

Spironolactone

EXPERIMENTAL

Drug: Spironolactone Drug: Placebo

Drug: Spironolactone

Placebo

EXPERIMENTAL

Drug: Placebo Drug: Spironolactone

Drug: Placebo

Interventions

SpironolactoneDRUG

50 mg po daily of spironolactone for 8 weeks. A cross-over study where each subject will receive spironolactone or placebo in a random order for 8 weeks each.

Also known as: Aldactone
Spironolactone
PlaceboDRUG

Each subject will receive placebo or spironolactone for 8 weeks. At the end of week 8, treatment arm for each subject will be blindly switched. So if a study patient received placebo for the first 8 weeks then he/she will be switched to receive active drug (spironolactone) for the next 8 weeks.

Also known as: sugar pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Body weight \> 40 kg
  • PAH Diagnostic Group I
  • Stable subjects with no change in PAH specific therapy within the last 4 weeks
  • No change in dose of background therapy (digoxin, diuretic) within the last 2 weeks excluding anticoagulation

You may not qualify if:

  • Unable to give informed consent
  • Hemodynamically unstable subjects
  • Pregnant or breast feeding
  • Have significant renal insufficiency (serum creatinine \>2.5 mg per deciliter or required hemodialysis)
  • Have significant liver dysfunction (AST or ALT more than three times upper limit of normal)
  • Currently on aldosterone receptor blocker (spironolactone or eplerenone) or ACE inhibitor
  • PH due to left heart disease
  • Unable or unwilling to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryHeart FailureEdema

Interventions

SpironolactoneSugars

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbohydrates

Study Officials

  • Zeenat Safdar, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeenat Safdar, MD

CONTACT

713-798-2400safdar@bcm.edu

Gwendolyn Goodloe

CONTACT

713-798-2400gmb@bcm.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 9, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

US(1)