Trial · NCT01377987

Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

NCT01377987, Not applicable, Completed, David Andrew Wellman; results first posted 2018-06-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients. Trials, record NCT01377987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01377987

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Trial

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

Title: Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
NCT number: NCT01377987
Status: Completed
Phases: Not applicable
Enrollment: 29 participants, actual
Lead sponsor: David Andrew Wellman
Conditions: Heart Failures
Interventions: Acetazolamide, Placebo
First posted: 2011-06-22
Last updated: 2018-06-13
Results first posted: 2018-06-13

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	1 week	The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.
Secondary	Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses	1 week	Chemoreflex "loop gain" was assessed according to Sands SA et al AJRCCM 2017 Jan 15;195(2):237-246. Loop gain is a unitless ratio measure that describes the magnitude of the increase in ventilation that occurs in response to a prior reduction in ventilation ("disturbance") and has units of L/min per L/min. A larger value indicates a more sensitive and unstable control system predisposing to oscillatory breathing. Loop gain was measured on the time scale of 1 min (i.e. response to a 1 cycle/min sinusoidal disturbance, referred to as "LG1"). The procedure involved brief administration of 7% carbon dioxide in air for 0.5 min ("pulses"); tests were repeated every 3 min for 30 min while measuring ventilation and carbon dioxide levels at the nose with patients awake and supine. measured using 0.5 min pulses of carbon dioxide.
Secondary	Sympathetic Activity (Urinary Norepinephrine)	1 week	Urinary norepinephrine levels overnight
Secondary	Left-atrial Volume	1 week	Left-atrial volume index, echocardiography, bi-plane method. Lower values were considered a favorable outcome. We considered values ≤28 mL/m\^2 to indicate normal left atrial volume. Values indicating graded left atrial enlargement were described as follows: mild (29-33 mL/m\^2), moderate (34-39 mL/m\^2), severe (≥40 mL/m\^2).
Secondary	Brain Natriuretic Peptide (NT-proBNP)	1 week	Brain natriuretic peptide (NT-proBNP) in morning
Secondary	Pittsburgh Sleep Quality Index	1 week	Pittsburgh Sleep Quality Index is a measure of self-reported sleep quality containing 19 questions that make up 7 component scores that are added to provide a total score. Total scores range from 0-21 (units on a scale) with higher scores representing reduced sleep quality. A score of 5 or more is interpreted as reduced sleep quality. The total score is reported.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	1 week	All participants who were randomized and completed the relevant study arm. Data are for non-REM supine sleep.	events per hour	MEAN
SECONDARY	Ventilatory Chemoreflex Sensitivity, Loop Gain Using Carbon Dioxide Pulses	1 week	All participants who completed the relevant arm. Morning data are reported.	unitless	MEAN
SECONDARY	Sympathetic Activity (Urinary Norepinephrine)	1 week	All participants who completed the relevant study arm	ug/g-creatinine	MEAN
SECONDARY	Left-atrial Volume	1 week	echocardiography could not be performed on one study due to rescheduling issues	mL/m^2	MEAN
SECONDARY	Brain Natriuretic Peptide (NT-proBNP)	1 week	All participants who completed the relevant arm	pg/ml	MEAN
SECONDARY	Pittsburgh Sleep Quality Index	1 week	All participants who participated in the relevant study arm.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	Acetazolamide	All participants	26.3	Standard Deviation 22.7	events per hour
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	Placebo	All participants	36.1	Standard Deviation 27.8	events per hour
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	Acetazolamide	Patients with sleep apnea	32.3	Standard Deviation 22.1	events per hour
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)	Placebo	Patients with sleep apnea	44.6	Standard Deviation 25.3	events per hour
Ventilatory Chemoreflex Sensitivity, Loop Gain Using Carbon Dioxide Pulses	Acetazolamide		0.40	Standard Deviation 0.16	unitless
Ventilatory Chemoreflex Sensitivity, Loop Gain Using Carbon Dioxide Pulses	Placebo		0.49	Standard Deviation 0.14	unitless
Sympathetic Activity (Urinary Norepinephrine)	Acetazolamide		40.8	Standard Deviation 23.6	ug/g-creatinine
Sympathetic Activity (Urinary Norepinephrine)	Placebo		35.0	Standard Deviation 17.3	ug/g-creatinine
Left-atrial Volume	Acetazolamide		34.3	Standard Deviation 12.1	mL/m^2
Left-atrial Volume	Placebo		40.0	Standard Deviation 13.5	mL/m^2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention (7 Days)	STARTED	Acetazolamide First, Then Placebo	14
First Intervention (7 Days)	STARTED	Placebo First, Then Acetazolamide	15
First Intervention (7 Days)	COMPLETED	Acetazolamide First, Then Placebo	14
First Intervention (7 Days)	COMPLETED	Placebo First, Then Acetazolamide	15
First Intervention (7 Days)	NOT COMPLETED	Acetazolamide First, Then Placebo	0
First Intervention (7 Days)	NOT COMPLETED	Placebo First, Then Acetazolamide	0
Washout (7 Days)	STARTED	Acetazolamide First, Then Placebo	14
Washout (7 Days)	STARTED	Placebo First, Then Acetazolamide	15
Washout (7 Days)	COMPLETED	Acetazolamide First, Then Placebo	13
Washout (7 Days)	COMPLETED	Placebo First, Then Acetazolamide	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

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	Fall without injury	General disorders	Acetazolamide	1	28	1
other	Fall without injury	General disorders	Placebo	0	28	0
other	Nocturia	Renal and urinary disorders	Acetazolamide	12	28	12
other	Nocturia	Renal and urinary disorders	Placebo	1	28	1
other	Taste Disturbance	Metabolism and nutrition disorders	Acetazolamide	4	28	4
other	Taste Disturbance	Metabolism and nutrition disorders	Placebo	0	28	0
other	Paresthesias	Nervous system disorders	Acetazolamide	5	28	5
other	Paresthesias	Nervous system disorders	Placebo	0	28	0
other	Fatigue	General disorders	Acetazolamide	3	28	3
other	Fatigue	General disorders	Placebo	1	28	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Acetazolamide	0	28
Total, all-cause mortality	Placebo	0	28
Total, other adverse events	Acetazolamide	17	28
Total, other adverse events	Placebo	6	28
Total, serious adverse events	Acetazolamide	0	28
Total, serious adverse events	Placebo	0	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Acetazolamide vs Placebo: deaths from any cause	Trial comparisons
Acetazolamide 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.

For software

Read this trial from software.

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

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GET https://conductscience.org/api/trials/v1/NCT01377987/registered

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