Trial · NCT01537926

Hypertrophic Regression With N-Acetylcysteine in HCM

NCT01537926, Phase 1, Completed, The University of Texas Health Science Center, Houston; results first posted 2021-11-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Hypertrophic Regression With N-Acetylcysteine in HCM. Trials, record NCT01537926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01537926

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Trial

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

Title: Hypertrophic Regression With N-Acetylcysteine in HCM
NCT number: NCT01537926
Status: Completed
Phases: Phase 1
Enrollment: 42 participants, actual
Lead sponsor: The University of Texas Health Science Center, Houston
Conditions: Hypertrophic Cardiomyopathy
Interventions: N-acetylcysteine, Placebo
First posted: 2012-02-23
Last updated: 2021-11-02
Results first posted: 2021-11-02
Limitations and caveats: The small sample size of the study prohibits from making firm conclusions about efficacy of NAC in hypertrophic cardiomyopathy (HCM).

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Recruitment as Assessed by Number of Participants Who Enrolled to the Study	at the time of enrollment
Primary	Retention as Assessed by Number of Participants Who Completed the Study	from baseline to 12 months
Primary	Compliance as Assessed by Percentage of Pills Taken by Participant	from baseline to 12 months	Participants returned all pill bottles to the study team, and the number of pills not taken by the participant (that is, the number of pills remaining in the bottles) were counted. Compliance is reported as percentage of pills taken by the participant.
Primary	Number of Participants With Side Effects Attributable to the Intervention	from baseline to 12 months
Primary	Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	baseline
Primary	Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	12 months
Secondary	Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography	12 months
Secondary	Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography	baseline
Secondary	Left Ventricular Mass (LVM) as Assessed by Echocardiography	baseline	Left Ventricular Mass (LVM) is the weight of the left heart and is estimated from the echocardiographic measurements that include left ventricular wall thickness and the chamber diameter. The weight is calculated in grams and then normalized to body surface area (m\^2), with LVM reported as g/m\^2.
Secondary	Left Ventricular Mass (LVM) as Assessed by Echocardiography	12 months	Left Ventricular Mass (LVM) is the weight of the left heart and is estimated from the echocardiographic measurements that include left ventricular wall thickness and the chamber diameter. The weight is calculated in grams and then normalized to body surface area (m\^2), with LVM reported as g/m\^2.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recruitment as Assessed by Number of Participants Who Enrolled to the Study	at the time of enrollment		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Retention as Assessed by Number of Participants Who Completed the Study	from baseline to 12 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Compliance as Assessed by Percentage of Pills Taken by Participant	from baseline to 12 months	Data are reported for participants for whom all pill bottles were returned to the study team. It was not known whether the returned bottles contained placebo or NAC; therefore, the data for both arms are reported together.	percentage of pills taken	MEAN
PRIMARY	Number of Participants With Side Effects Attributable to the Intervention	from baseline to 12 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	baseline	Data are reported for all participants who completed the study.	millimeters (mm)	MEAN
PRIMARY	Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	12 months	Data are reported for all participants who completed the study.	millimeters (mm)	MEAN
SECONDARY	Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography	12 months	Data are reported for all participants who completed the study.	millimeters (mm)	MEAN
SECONDARY	Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography	baseline	Data are reported for all participants who completed the study.	millimeters (mm)	MEAN
SECONDARY	Left Ventricular Mass (LVM) as Assessed by Echocardiography	baseline	Data are reported for all participants who completed the study.	g/m^2	MEAN
SECONDARY	Left Ventricular Mass (LVM) as Assessed by Echocardiography	12 months	Data are reported for all participants who completed the study.	g/m^2	MEAN

Source ClinicalTrials.gov

Results by group19

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

Outcome	Group	Value	Spread	Units
Recruitment as Assessed by Number of Participants Who Enrolled to the Study	N-acetylcysteine (NAC)	29		Participants
Recruitment as Assessed by Number of Participants Who Enrolled to the Study	Placebo	13		Participants
Retention as Assessed by Number of Participants Who Completed the Study	N-acetylcysteine (NAC)	24		Participants
Retention as Assessed by Number of Participants Who Completed the Study	Placebo	11		Participants
Compliance as Assessed by Percentage of Pills Taken by Participant	All Participants	92	Standard Deviation 0.0878	percentage of pills taken
Number of Participants With Side Effects Attributable to the Intervention	N-acetylcysteine (NAC)	0		Participants
Number of Participants With Side Effects Attributable to the Intervention	Placebo	0		Participants
Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	N-acetylcysteine (NAC)	18.88	Standard Deviation 4.59	millimeters (mm)
Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	Placebo	18.00	Standard Deviation 3.97	millimeters (mm)
Interventricular Septal Thickness (IVST) as Assessed by Echocardiography	N-acetylcysteine (NAC)	17.92	Standard Deviation 3.3	millimeters (mm)

1 to 10 of 19Source ClinicalTrials.gov

See all 19 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	N-acetylcysteine (NAC)	29
Overall Study	STARTED	Placebo	13
Overall Study	COMPLETED	N-acetylcysteine (NAC)	24
Overall Study	COMPLETED	Placebo	11
Overall Study	NOT COMPLETED	N-acetylcysteine (NAC)	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events10

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	Skin Rash	Skin and subcutaneous tissue disorders	N-acetylcysteine (NAC)	2	29	2
other	Skin Rash	Skin and subcutaneous tissue disorders	Placebo	0	13
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	N-acetylcysteine (NAC)	2	29	2
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	Placebo	0	13	0
serious	Cerebrovascular accident	Vascular disorders	N-acetylcysteine (NAC)	2	29	2
serious	Cerebrovascular accident	Vascular disorders	Placebo	0	13	0
serious	Seizure	Nervous system disorders	N-acetylcysteine (NAC)	1	29	1
serious	Seizure	Nervous system disorders	Placebo	0	13	0
serious	Chest pain	General disorders	N-acetylcysteine (NAC)	1	29	1
serious	Chest pain	General disorders	Placebo	0	13	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	N-acetylcysteine (NAC)	0	29
Total, all-cause mortality	Placebo	0	13
Total, other adverse events	N-acetylcysteine (NAC)	2	29
Total, other adverse events	Placebo	0	13
Total, serious adverse events	N-acetylcysteine (NAC)	5	29
Total, serious adverse events	Placebo	0	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29540445	RESULT

Source PubMed

Grants0

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.

None in this release.

Trial comparisons5

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

Comparison	Source
N-acetylcysteine (NAC) vs Placebo: Number of Participants With Side Effects Attributable to the Intervention	Trial comparisons
N-acetylcysteine (NAC) vs Placebo: Recruitment as Assessed by Number of Participants Who Enrolled to the Study	Trial comparisons
N-acetylcysteine (NAC) vs Placebo: Retention as Assessed by Number of Participants Who Completed the Study	Trial comparisons
N-acetylcysteine (NAC) vs Placebo: deaths from any cause	Trial comparisons
N-acetylcysteine (NAC) vs Placebo: serious adverse events	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.

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