Clinical trial

Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure

Name

010189-1

Description

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

Trial arms

Trial start

2017-09-21

Estimated PCD

2024-09-21

Trial end

2024-12-21

Status

Recruiting

Treatment

continuous positive airway pressure (CPAP)

Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.

Arms:

CPAP (continuous positive airway pressure)

Other names:

CPAP

Placebo

Placebo pill or patch. Single dose

Arms:

Placebo pill or patch or sham CPAP

Other names:

placebo pill or patch

Size

Primary endpoint

Supine Systolic Blood Pressure

12 hours

Eligibility criteria

Inclusion Criteria: * Patients with autonomic failure and with supine hypertension from all races Exclusion Criteria: * All medical students * Pregnant women * High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction) * History of serious allergies or asthma.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2024-03-26

1 organization

1 drug

2 indications

Organization

Vanderbilt University Medical Center

Drug

Varlilumab

Indication

Supine Hypertension

Indication

Autonomic Failure