Trial · NCT00115349

Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases

NCT00115349, Phase 2, Terminated, Carelon Research; results first posted 2014-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases. Trials, record NCT00115349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00115349

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases
NCT number: NCT00115349
Status: Terminated
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Carelon Research
Conditions: Cardiovascular Diseases, Heart Diseases, Beta-Thalassemia
Interventions: Deferoxamine, Deferiprone (L1)
First posted: 2005-06-22
Last updated: 2018-03-01
Results first posted: 2014-01-14
Limitations and caveats: The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Left Ventricular Ejection Fraction (LVEF).	Baseline to one year	The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.
Secondary	Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.	one year
Secondary	Change in Left Ventricular (LV) Volume From Screening to One Year.	one year
Secondary	Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.	one year
Secondary	Change in Holter Monitor Scores From Baseline to One Year.	one year
Secondary	Initiation of or Increase in Cardiac Medications	continuous
Secondary	Adverse Events	continous

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Left Ventricular Ejection Fraction (LVEF).	Baseline to one year	Percent of the blood in left ventricle	LEAST_SQUARES_MEAN
SECONDARY	Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.	one year
SECONDARY	Change in Left Ventricular (LV) Volume From Screening to One Year.	one year
SECONDARY	Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.	one year
SECONDARY	Change in Holter Monitor Scores From Baseline to One Year.	one year
SECONDARY	Initiation of or Increase in Cardiac Medications	continuous
SECONDARY	Adverse Events	continous

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Left Ventricular Ejection Fraction (LVEF).	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy		7.2	Standard Error 1.9	Percent of the blood in left ventricle
Change in Left Ventricular Ejection Fraction (LVEF).	Deferoxamine (DFO) + Monotherapy		6.3	Standard Error 3.3	Percent of the blood in left ventricle

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	11
Overall Study	STARTED	Deferoxamine (DFO) + Monotherapy	9
Overall Study	COMPLETED	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	0
Overall Study	COMPLETED	Deferoxamine (DFO) + Monotherapy	0
Overall Study	NOT COMPLETED	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	11
Overall Study	NOT COMPLETED	Deferoxamine (DFO) + Monotherapy	9

Source ClinicalTrials.gov

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abnormal LFTs	Blood and lymphatic system disorders	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	1	11	1
other	Abnormal LFTs	Blood and lymphatic system disorders	Deferoxamine (DFO) + Monotherapy	0	9	0
other	Bilerateral Hip Pain	Musculoskeletal and connective tissue disorders	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	1	11	1
other	Bilerateral Hip Pain	Musculoskeletal and connective tissue disorders	Deferoxamine (DFO) + Monotherapy	0	9	0
other	Chest Ache	Respiratory, thoracic and mediastinal disorders	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	1	11	1
other	Chest Ache	Respiratory, thoracic and mediastinal disorders	Deferoxamine (DFO) + Monotherapy	0	9	0
other	Common Cold	Social circumstances	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	1	11	2
other	Common Cold	Social circumstances	Deferoxamine (DFO) + Monotherapy	0	9	0
other	Dizziness	General disorders	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	2	11	2
other	Dizziness	General disorders	Deferoxamine (DFO) + Monotherapy	0	9	0

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy
Total, all-cause mortality	Deferoxamine (DFO) + Monotherapy
Total, other adverse events	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	8	11
Total, other adverse events	Deferoxamine (DFO) + Monotherapy	6	9
Total, serious adverse events	Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy	6	11
Total, serious adverse events	Deferoxamine (DFO) + Monotherapy	3	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37975597	DERIVED

Source PubMed

Grants5

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01HL065232	Thalassemia Clinical Research Network	KWIATKOWSKI, JANET L	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2000 to 2009	NIH RePORTER
U01HL065238	Thalassemia Clinic Research Network	MCKINLAY, SONJA M	NEW ENGLAND RESEARCH INSTITUTES, INC.	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2000 to 2009	NIH RePORTER
U01HL065239	Thalassemia Clinical Research Network	VICHINSKY, ELLIOTT P	CHILDREN'S HOSPITAL & RES CTR AT OAKLAND	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2000 to 2009	NIH RePORTER
U01HL065244	Thalassemia Clinical Research Network	GIARDINA, PATRICIA J	WEILL MEDICAL COLL OF CORNELL UNIV	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2000 to 2009	NIH RePORTER
U01HL065260	Thalassemia Clinical Research Network	NEUFELD, ELLIS J	BOSTON CHILDREN'S HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2000 to 2009	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy vs Deferoxamine (DFO) + Monotherapy: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00115349

GET https://conductscience.org/api/trials/v1/NCT00115349/events?page=2

API reference For AI assistants